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pdfSection 8(d) Health Safety Data
Reporting User Guide – Primary
Authorized Official
Environmental Protection Agency
Office of Pollution Prevention and Toxics
Manage Toxic Substances
Delivery Order # GS00Q09BGD0022
Task Order # EP-G11H-00154
Project # TDD 9.21
Version 2.0
October 22, 2013
Table of Contents
1
Introduction ........................................................................................................................1
1.1
2
Labeling Confidential Information .................................................................................1
System Requirements ........................................................................................................4
2.1
Supported Browsers .....................................................................................................4
2.2
Screen Resolution ........................................................................................................4
3
Primary Authorized Official Functions .................................................................................5
3.1
Log into Section 8(d) Health & Safety Data Reporting application ................................5
3.2
Home Screen Navigation ..............................................................................................6
3.3
User Management ........................................................................................................8
3.4
Create New Submission .............................................................................................10
3.4.1
Section 8(d) Health & Safety Data Reporting Submissions ................................... 10
3.4.2
Create Passphrase Screen ...................................................................................12
3.4.3
Enter Passphrase Screen .....................................................................................13
3.4.4
Navigation Tree ....................................................................................................14
3.4.5
Action Bar .............................................................................................................17
3.4.6
General Submission Information Screen ...............................................................18
3.4.7
Technical Contact Information Screen ..................................................................19
3.4.8
Submitting on Behalf Of Company Screen ............................................................22
3.4.9
Chemical Substance Identity of Impurities Screen ................................................23
3.4.10
Study Identification Screen ...................................................................................28
3.4.11
Full Study Report Screen ......................................................................................30
3.4.12
Initiated Studies Screen ........................................................................................33
3.4.13
Ongoing Studies Screen .......................................................................................38
3.4.14
Robust Summary Screen ......................................................................................43
3.4.15
Studies Which Are Known But Without Possession of Copies Screen .................. 45
3.4.16
Studies Previously Sent to Federal Agencies without Confidentiality Claims Screen51
3.5
4
EPA Request for Further Information ..........................................................................56
3.5.1
Underlying Data Screen ........................................................................................56
3.5.2
Preliminary Report of Ongoing Studies Screen .....................................................58
3.5.3
Copies of Studies Screen .....................................................................................65
3.6
Submitter Requests Screen ........................................................................................70
3.7
Substantiation Summary.............................................................................................71
Validate ............................................................................................................................74
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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5
Submit to EPA via CDX ....................................................................................................76
5.1
Submitting Official Information Screen ........................................................................76
5.2
Submission Process: Validation Screen .....................................................................77
5.3
Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen ....... 78
5.4
Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen ................. 79
5.5
CROMERR Security Question Screen ........................................................................80
5.6
Submit to CDX Screen................................................................................................81
5.7
Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen........ 82
6
Download Copy of Record ................................................................................................84
7
Create an Amendment .....................................................................................................86
8
Resources ........................................................................................................................88
Appendix A. Definitions, Acronyms, and Abbreviations .............................................................90
Appendix B. Submission Types, Effects, and Endpoints ...........................................................91
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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List of Exhibits
Exhibit 3-1: Chemical Information Submission System Screen ...................................................6
Exhibit 3-2: Section 8(d) Health & Safety Data Reporting Home Screen .....................................8
Exhibit 3-3: User Management Screen ......................................................................................10
Exhibit 3-4: Section 8(d) Health & Safety Data Reporting Submissions Screen......................... 12
Exhibit 3-5: Create Passphrase Screen.....................................................................................13
Exhibit 3-6: Enter Passphrase Screen .......................................................................................14
Exhibit 3-7: Navigation Prompt ..................................................................................................15
Exhibit 3-8: Navigation Tree ......................................................................................................16
Exhibit 3-9: Action Bar – Validate ..............................................................................................17
Exhibit 3-10: Action Bar – Save .................................................................................................17
Exhibit 3-11: Action Bar – Preview ............................................................................................17
Exhibit 3-12: Action Bar – Submit ..............................................................................................18
Exhibit 3-13: Action Bar – Links ................................................................................................18
Exhibit 3-14: General Submission Information Screen ..............................................................19
Exhibit 3-15: Technical Contact Information Screen ..................................................................21
Exhibit 3-16: Submitting on Behalf of Company Screen ............................................................23
Exhibit 3-17: Chemical Substance Identity of Impurities Screen ................................................24
Exhibit 3-18: Search Substance Registry Services Pop-Up Window ......................................... 26
Exhibit 3-19: Chemical Not Found in Substance Registry Services Pop-Up Window ................ 27
Exhibit 3-20: Study Identification Screen ...................................................................................29
Exhibit 3-21: Study Identification Screen for an Amendment .....................................................30
Exhibit 3-22: Full Study Report Screen .....................................................................................31
Exhibit 3-23: Full Study Report Pop-Up Window .......................................................................33
Exhibit 3-24: Initiated Studies Screen (Add Document) .............................................................35
Exhibit 3-25: Initiated Studies Pop-Up Window .........................................................................36
Exhibit 3-26: Initiated Studies Screen (Add Study) ....................................................................37
Exhibit 3-27: Ongoing Studies Screen (Add Document) ............................................................40
Exhibit 3-28: Ongoing Studies Pop-Up Window ........................................................................41
Exhibit 3-29: Ongoing Studies Screen (Add Study) ...................................................................42
Exhibit 3-30: Robust Summary Screen .....................................................................................43
Exhibit 3-31: Robust Summary Pop-Up Window .......................................................................45
Exhibit 3-32: Studies Which Are Known but without Possession of Copies (Add Document)..... 47
Exhibit 3-33: Studies Which Are Known but without Possession of Copies Pop-Up Window ..... 49
Exhibit 3-34: Studies Which Are Known but without Possession of Copies Screen (Add Study)50
Exhibit 3-35: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Screen (Add Document)............................................................................................................53
Exhibit 3-36: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Pop-Up Window ........................................................................................................................54
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Exhibit 3-37: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Screen (Add Study) ...................................................................................................................55
Exhibit 3-38: Underlying Data Screen .......................................................................................57
Exhibit 3-39: Underlying Data Pop-Up Window (with Sanitized Document Attached) ................ 58
Exhibit 3-40: Preliminary Reports of Ongoing Studies Screen (Add Document) ........................ 61
Exhibit 3-41: Preliminary Report of Ongoing Studies Pop-Up Window (with Sanitized Document
Attached) ..................................................................................................................................63
Exhibit 3-42: Preliminary Report of Ongoing Studies Screen (Add Study) ................................. 64
Exhibit 3-43: Copies of Studies Screen (Add Document) ..........................................................67
Exhibit 3-44: Copies of Studies Pop-up Window (with Sanitized Document Attached) .............. 68
Exhibit 3-45: Copies of Studies Screen (Add Study) .................................................................69
Exhibit 3-46: Submitter Requests Screen ..................................................................................70
Exhibit 3-47: Submitter Request Pop-Up Window .....................................................................71
Exhibit 3-48: Substantiation Summary Screen ..........................................................................72
Exhibit 3-49: Submission of Studies Substantiation Screen ......................................................73
Exhibit 4-1: Section 8(d) Health & Safety Data Reporting Validation Pop-Up Window ............... 75
Exhibit 5-1: Submitting Official Information Screen....................................................................76
Exhibit 5-2: Submission Process: Validation Screen .................................................................77
Exhibit 5-3: Submission Process: PDF Generation Screen .......................................................78
Exhibit 5-4: Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen ... 79
Exhibit 5-5: Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen ............. 80
Exhibit 5-6: Cross-Media Electronic Reporting Regulation (CROMERR) Security Question
Screen ......................................................................................................................................81
Exhibit 5-7: Submit to CDX Screen ...........................................................................................82
Exhibit 5-8: Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen ... 83
Exhibit 6-1: Download Copy of Record Screen..........................................................................84
Exhibit 6-2: Download Prompt Screen.......................................................................................85
Exhibit 7-1: Section 8(d) Health & Safety Data Reporting Submissions Screen – Amendment.. 86
Exhibit 7-2: Unlock Prompt Message ........................................................................................87
Exhibit 8-1: Resources Screen ..................................................................................................89
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Primary Authorized Official
October 22, 2013
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1
Introduction
This document presents the user guide for the Office of Pollution Prevention and Toxics (OPPT)
Section 8(d) Health & Safety Data Reporting application submission process. This document is
the user guide for the Primary Authorized Official (AO) user of the Section 8(d) Health & Safety
Data Reporting tool.
The Primary AO is the person legally responsible for the submission of 8(d) Health & Safety
Data Reporting data for the reporting company. The AO, typically, is a senior official for the
reporting company and may be the supervisor of the person (or persons) completing the form.
As a Primary AO, you can create a new form. You can also assign Supports to edit and complete
forms on your behalf. You are responsible for submitting all required information and are legally
responsible for the information submitted to EPA within each 8(d) Health & Safety Data
Reporting submission.
General information on Section 8(d) Health & Safety Data Reporting is available at
http://www.epa.gov/oppt/chemtest/ereporting/index.html. Information on CDX registration,
including user roles that apply to completing a Section 8(d) Health & Safety Data Reporting is
available at http://cdx.epa.gov/About/UserGuide
Toxic Substances Control Act (TSCA) regulations require industry to provide the Environmental
Protection Agency (EPA) with documentation regarding chemical production, manufacture,
distribution, use, disposal, import, and export. As a result, the implementation of TSCA has
generated a large volume of documents submitted to the Agency by the regulated community.
The Section 8(d) Health & Safety Data Reporting application is the electronic, web-based tool
provided by the Environmental Protection Agency (EPA) for the submission of Section 8(d)
Health & Safety Data Reporting data. As a Primary AO, you can create or modify a Section 8(d)
Health & Safety Data Reporting submission as well as submit it to EPA via the Central Data
Exchange (CDX). You can also create Section 8(d) Health & Safety Data Reporting submission
amendments and download the Copy of Record (CoR).
For questions concerning the Toxic Substances Control Act (TSCA) Section 8(d) Health &
Safety Data Reporting software requirements, please contact the CDX Help Desk at
[email protected] or call 1-888-890-1995 between the hours of 8am – 6pm Eastern Standard
Time (EST). For TSCA Section 8(d) Health & Safety Data Reporting requirements, please
contact the TSCA Hotline at [email protected] or call 202-554-1404.
1.1
Labeling Confidential Information
This user guide presents instructions and screenshots for the ‘Section 8(d) Health & Safety Data
Reporting’ electronic application as if you were logged in as the Primary AO. As the Primary
AO you are able to create, modify, delete, and submit an 8(d) submission. The user may claim
certain information as Confidential Business Information (CBI). If the data is claimed as CBI, it
will be treated in accordance with Agency confidentiality regulations at 40 CFR part 2, subpart
B.
This TSCA Section 8(d) Health & Safety Data Reporting electronic application is optional for
the production and submission of these filings. The paper option for filing will continue to be
allowed.
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Potential users may find that the use of this application saves time, burden and, because it is in an
electronic format, provides easy access to reporting forms. Potential users are reminded to
carefully read and follow application instructions. Persons who wish to use this application must
address all provisions in the application, including those relating to indexing information (i.e.,
company name, address, chemical name etc.) and those related to CBI submissions, including the
requirement for the submission of sanitized or redacted filings.
Please note that certain CBI claims will not be accepted if you choose to use this electronic
application for TSCA Section 8(d) Health & Safety Data Reporting. For example, chemical
name and/or chemical identity, if the chemical is listed on the public portion of the TSCA
Inventory, may not be claimed as CBI in a submission using this application.
If the user believes that, these or other data elements should be treated as CBI, then the user may
use the paper option to file the Section 8(d) Health & Safety Data Reporting form and assert CBI
claims.
If the user claims an uploaded document as CBI, a sanitized document must be provided.
The following fields can be claimed as CBI within the ‘Section 8(d) Health & Safety Data
Reporting’ application:
• Technical Contact Information
• Submitting on Behalf of Company information
• A single chemical substance that is not on the public TSCA Inventory
• Any document uploaded on the following screens:
o Full Study
o Initiated Studies
o Ongoing Studies
o Studies which are known but without possession of copies
o Underlying Data
o Preliminary Reports of Ongoing Studies
o Copies of Studies
• Laboratory information on the following screens:
o Initiated Studies
o Ongoing Studies
o Studies Which are Known but Without Possession of Copies
o Studies Previously Sent to Federal Agencies Without Confidentiality Claims
o Preliminary Reports of Ongoing Studies
• Contact information on the following screens:
o Studies Which are Known but Without Possession of Copies
o Studies Previously Sent to Federal Agencies Without Confidentially Claims
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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o Copies of Studies
• Submitter Official Information
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Primary Authorized Official
October 22, 2013
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2
System Requirements
To use the Section 8(d) Health & Safety Data Reporting application to submit a Section 8(d)
Health & Safety Data Reporting submission, the following are required:
• An e-mail account
• A supported web browser (see Section 2.1 below) with Java Script enabled.
• Internet access
• Adobe Acrobat Reader 5.0 or higher
• CDX username and password
2.1
Supported Browsers
• Internet Explorer 7 or above
− Go to the following link to download:
http://windows.microsoft.com/en-US/internet-explorer/downloads/ie
• Mozilla Firefox 3.5 or above
− Go to the following link to download:
http://www.mozilla.com/en-US/firefox/all-older.html
• Safari 4 or above
− Go to the following link to download:
http://support.apple.com/kb/dl877
• Google Chrome
− Go to the following link to download:
http://www.google.com/chrome
2.2
Screen Resolution
Screen resolution should be set to 1024 x 768 or greater.
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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3
Primary Authorized Official Functions
This section describes how to:
• Access the application
• Navigate to the Section 8(d) Health & Safety Data Reporting ‘Home’ screen
• Assign Supports to complete a submission
• Start and complete a Section 8(d) Health & Safety Data Reporting submission
• Submit to EPA via CDX
• Download the Copy of Record
• Create an amendment
The Primary AO is the person legally responsible for the submission of 8(d) Health & Safety
Data Reporting data for the reporting company. The AO, typically, is a senior official for the
reporting company and may be the supervisor of the person (or persons) completing the form.
As a Primary AO, you can create a new form. You can also assign Supports to edit and complete
forms on your behalf. You are responsible for submitting all required information and are legally
responsible for the information submitted to EPA within each 8(d) Health & Safety Data
Reporting submission.
You can save the submission at any point during the data entry process. The save functionality
will allow you to return to that same submission at any point in the future. You can print the
document at any point; however, the ‘Not For Submission’ watermark will be placed on the
portable document format (PDF) document each time the submission is printed.
3.1
Log into Section 8(d) Health & Safety Data Reporting application
After you create an account in CDX and click the ‘Primary Authorized Official’ link under the
Chemical Safety and Pesticide Programs (CSPP) program service, you will be taken to the
‘Chemical Information Submission System’ screen.
Note: Information on CDX registration, including user roles that apply to completing a Section
8(e) Notice, is available at http://cdx.epa.gov/About/UserGuide
Exhibit 3-1 shows the screen capture for 'Chemical Information Submission System' screen.
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Exhibit 3-1: Chemical Information Submission System Screen
Navigation: Select ‘TSCA Section 8(d) Health & Safety Data Reporting’ from the drop-down
menu and click the ‘OK’ button to navigate to the Section 8(d) Health & Safety Data Reporting
‘Home’ screen.
3.2
Home Screen Navigation
You can access the Section 8(d) Health & Safety Data Reporting ‘Home’ screen by selecting
‘TSCA Section 8(d) Health & Safety Data Reporting’ from the ‘Chemical Information
Submission System’ screen drop-down menu and by clicking the ‘OK’ button.
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Primary Authorized Official
October 22, 2013
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The Section 8(d) Health & Safety Data Reporting ‘Home’ screen is the first screen within the
Section 8(d) Health & Safety Data Reporting application. It provides you with links and tabs to
access the ‘Section 8(d) Health & Safety Data Reporting’ submissions screen, ‘User
Management,’ and ‘Resources’ screens. To navigate to any of these screens, click the screen link
(hyperlinked in blue text), or click the screen tab (located within the application header). The
links and tabs provide the same functionality.
• Submissions: Click the ‘Submissions’ link or tab to navigate to the ‘Section 8(d) Health &
Safety Data Reporting’ submissions screen. You can create or modify a Section 8(d) Health
& Safety Data Reporting submission using the ‘Section 8(d) Health & Safety Data
Reporting’ submissions screen. For additional details about the ‘Section 8(d) Health & Safety
Data Reporting’ submissions screen, please refer to Section 3.4.1.
• User Management: Click the ‘User Management’ link or tab to navigate to the ‘User
Management’ screen. You can manage the access rights of Supports per submission using the
‘User Management’ screen. For additional details about the ‘User Management’ screen,
please refer to Section 3.3.
• Resources: Click the ‘Resources’ link or tab to navigate to the ‘Resources’ screen. You can
find the Section 8(d) Health & Safety Data Reporting user guide, as well as useful links for
further usability instruction on the ‘Resources’ screen. For additional details about the
‘Resources’ screen, please refer to Section 8.
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Exhibit 3-2 shows a screen capture for the Section 8(d) Health & Safety Data Reporting ‘Home’
screen:
Exhibit 3-2: Section 8(d) Health & Safety Data Reporting Home Screen
Navigation: Click the ‘User Management’ link or tab to access the ‘User Management’ screen
and assign Supports.
3.3
User Management
You can access the ‘User Management’ screen by clicking the ‘User Management’ link from the
Section 8(d) Health & Safety Data Reporting ‘Home’ screen, or by clicking the ‘User
Management’ tab from the application header.
On the ‘User Management’ screen, you can assign Supports to fill out a Section 8(d) Health &
Safety Data Reporting submission. You have the ability to assign one or more Supports to have
access to the ‘Section 8(d) Health & Safety Data Reporting’ application to modify submissions
you created. You must first create a new submission before you can assign Supports. For
instructions on how to create a new submission, please refer to Section 3.4.
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Submission Alias: No values will be available in this menu until a submission has been created.
For instructions on how to create a new submission, please refer to Section 3.4. Select a
submission from the ‘Submission Alias’ drop-down menu to begin assigning Supports. Once a
submission has been selected, the ‘Assign Users’ group box will update to display the Supports
who have identified you as their AO during CDX registration.
Assign Users to Submission: This box shows all the Supports you can assign to complete a
Section 8(d) Health & Safety Data Reporting submission for the selected submission. To move
Supports from the ‘Unassigned’ group box to the ‘Assigned’ group box, highlight individual or
multiple Supports and click the ‘add >>’ button. To move Supports from the ‘Assigned’ group
box to the ‘Unassigned’ group box, highlight individual or multiple Supports and click the
‘< key on your keyboard while clicking each Support. To highlight multiple
consecutive Supports, hold down the key on your keyboard while clicking the first
and last Supports in the list.
• Assigned: This box contains the Supports who have been given permission, by you, to access
and edit the selected submission. To move Supports from the ‘Assigned’ group box to the
‘Unassigned’ group box, highlight individual or multiple Supports and click the ‘<< remove’
button. To highlight multiple Supports hold down the key on your keyboard and click
each Support. To highlight multiple consecutive Supports, hold down the key on
your keyboard and click the first and last Supports in the list.
When you have finished assigning Supports, click the ‘Save’ button to save the selection. To
navigate away from the ‘User Management’ screen, you can click the CSPP logo, ‘Home’ tab
‘Submissions’ tab or ‘Resources’ tab located within the application header.
Exhibit 3-3 shows a screen capture of the ‘User Management’ screen:
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Exhibit 3-3: User Management Screen
Navigation: Click the ‘Submissions’ tab located within the application header to navigate to the
‘Section 8(d) Health & Safety Data Reporting’ submissions screen.
3.4
Create New Submission
As a Primary AO, you can create, modify, delete a new submission, and assign your Supports to
complete identified submissions.
3.4.1
Section 8(d) Health & Safety Data Reporting Submissions
You can access the ‘Section 8(d) Health & Safety Data Reporting’ submissions screen by
clicking the ‘Submissions’ link from the Section 8(d) Health & Safety Data Reporting ‘Home’
screen or by clicking the ‘Submissions’ tab located within the application header.
Each column within the table of the ‘Section 8(d) Health & Safety Data Reporting’ submissions
screen can be sorted by clicking the column headers.
Start a New Submission: To create a new Section 8(d) Health & Safety Data Reporting
submission, select a Federal Register Notice (FRN) from the ‘Select Applicable CFR/FRN’
drop-down menu for the chemical substance you are reporting, and click the ‘Start New
Submission’ button. You will be required to create a passphrase that will be associated with that
particular submission. Make sure to create a passphrase that you will remember, as it cannot be
retrieved or reset. Refer to Section 3.4.2 for further instructions on creating a passphrase.
Edit a Submission: To modify an existing Section 8(d) Health & Safety Data Reporting
submission, click the ‘Submission Alias’ link for a submission that has a status of ‘In Progress’
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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within the ‘Status’ column. You will be required to enter the passphrase associated with that
particular submission to access and continue editing the submission.
Creating Amendments: To edit a submitted Section 8(d) Health & Safety Data Reporting
submission (i.e., to create an amendment), you must first unlock the particular submission by
clicking the ‘Lock’ icon ( ) under the ‘Action’ column. You will be required to enter the
passphrase associated with that particular submission to gain access and amend the submission.
All further changes will be submitted as an amendment. Refer to Section 7 for further
instructions on creating an amendment.
The ‘Section 8(d) Health & Safety Data Reporting’ submissions screen displays the following
column headers:
• Submission Alias: Displays a clickable link for submissions with a status of ‘In Progress.’
Clicking this link will navigate you to the ‘Enter Passphrase’ screen.
• FRN/CFR: Displays the FRN or CFR.
• CASRN: Displays the Chemical Abstract Services Registry Number (CASRN). The
‘CASRN’ column will display as blank until you have identified the submission type and
started a new submission.
• Last Modified: Displays the date the submission was last accessed.
• Submission Date: Displays the date the form was submitted to CDX. This date populates
only after you complete a submission.
• Copy of Record: Click the ‘Copy of Record’ icon to navigate to the ‘Cross-Media Electronic
Reporting Regulation (CROMERR) Login’ screen and continue the download copy of record
process. The ‘Copy of Record’ icon is displayed only after you complete the submission. The
‘Copy of Record’ icon is confirmation that your submission was successfully received by
EPA. Click the ‘Copy of Record’ icon to download the copy of record to your hard drive.
Note that the ‘Copy of Record’ icon may take 15-20 minutes to display on the ‘Section 8(d)
Health & Safety Data Reporting’ submissions screen. Refer to Section 6 for further
instructions on downloading the copy of record.
• Action: Displays a ‘Delete’ icon ( ) for all submissions with a status of ‘In Progress.’
Displays a ‘Lock’ icon ( ) for all submissions that have been submitted. Only an AO can
unlock a submission by clicking the ‘Unlocked’ icon ( ).
Items per page: The ‘Section 8(d) Health & Safety Data Reporting’ submissions screen allows
you to display a specific number of submissions per page. The ‘Items per page’ drop-down menu
allows you to view ‘25,’ ‘50,’ ‘75,’ or ‘100’ submissions per page.
Export options: Displays ‘CSV,’ ‘Excel,’ ‘XML,’ and ‘PDF’ links for you to export the
‘Section 8(d) Health & Safety Data Reporting’ submissions screen in one of the specified
formats as an Excel spreadsheet, Comma-Separated Values (CSV), Extensible Markup Language
(XML), or Portable Document Format (PDF).
Select Applicable CFR/FRN: Displays the FRN/CFR citations that are available for the user to
select and create a new submission.
Start New Submission: Click the button to start a new submission and navigate to the ‘Create
New Passphrase’ screen.
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Exhibit 3-4 shows a screen capture of the ‘Section 8(d) Health & Safety Data Reporting’
submissions screen:
Exhibit 3-4: Section 8(d) Health & Safety Data Reporting Submissions Screen
Navigation: Select the appropriate option from the ‘Select Applicable CFR/FRN’ drop-down
menu and click the ‘Start New Submission’ button to navigate to the ‘Create Passphrase’ screen.
3.4.2
Create Passphrase Screen
To start a new Section 8(d) Health & Safety Data Reporting submission, select an FRN/CFR
from the ‘Select Applicable CFR/FRN’ drop-down menu and click the ‘Start New Submission’
button on the ‘Section 8(d) Health & Safety Data Reporting’ submissions screen. The ‘Create
Passphrase’ screen allows you to create a passphrase and associate that passphrase with the
submission. The application uses the passphrase as an encryption key to protect the contents of
the submission. You are responsible for remembering the passphrase and distributing it to the
appropriate individuals. ‘If you lose or forget the passphrase, you must create a new form and
passphrase. For security reasons, the system administrator does not have access to the passphrase
and will not be able to retrieve it or reset it to a new one.’
New Passphrase: To associate a passphrase with a submission, enter a passphrase that is at least
8 characters in length. To protect your account, your passphrase should contain a combination of
letters and numbers. The passphrase you create may include spaces, but may not contain special
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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characters (for example, +, and *). You can associate the same passphrase with multiple
submissions.
You will be responsible for remembering the passphrase and distributing it to only authorized
Supports for the submission. If you forget the passphrase, you will not be able to access the
Section 8(d) Health & Safety Data Reporting submission to print, submit, or make changes.
Exhibit 3-5 shows a screen capture of the ‘Create Passphrase’ screen:
Exhibit 3-5: Create Passphrase Screen
Navigation: Create a passphrase and click the ‘Next’ button to navigate to the ‘General
Submission Information’ screen.
3.4.3
Enter Passphrase Screen
To access a submission that is in progress, click the ‘Submission Alias’ link for a submission
with a status of ‘In Progress’ on the ‘Section 8(d) Health & Safety Data Reporting’ submissions
screen. The ‘Enter Passphrase’ screen allows you to enter the passphrase that is associated with
the submission.
Enter Passphrase: Enter the passphrase that you originally created and associated with the
submission.
Exhibit 3-6 shows a screen capture of the ‘Enter Passphrase’ screen:
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Exhibit 3-6: Enter Passphrase Screen
Navigation: Enter the passphrase that you originally created and associated with the submission
and click the ‘Next’ button to navigate to the ‘General Submission Information’ screen.
3.4.4
Navigation Tree
The navigation tree is located on the left hand side of each screen. You can perform the
following functions using the navigation tree:
• Collapse and expand folders: Each section of the submission falls under a collapsible
folder within the navigation tree, which allows you to save space or easily view items in the
navigation tree. When a folder is expanded, you can click the minus sign (-), the ‘Folder’
icon ( ), or the folder title link to collapse that section of the navigation tree. When a
folder is collapsed, you can click the plus sign (+), the ‘Folder’ icon ( ), or the folder title
link to expand that section of the navigation tree. When you place your cursor over a folder
title link, it will highlight in red.
• Open and close the navigation tree: To provide more visual form space, a navigation
arrow ( ) that opens and closes the navigation tree is located to the right of the navigation
tree. Click the arrow ( ) to close the navigation tree and increase the space of the
submission content. Likewise, click the arrow ( ) on the closed navigation tree to open the
navigation tree.
• Navigate between screens: You can use the navigation tree to navigate between the
various screens within the application. Each screen of the submission is denoted with a
‘Form’ icon ( ). You can click the ‘Form’ icon ( ) or the screen title link to navigate to
the selected screen. You are required to save all information entered on a particular screen
before navigating to the next screen or all entered information will be lost. A prompt will
appear after you click a link in the navigation tree indicating, ‘Are you sure you want to
leave the current page? Any unsaved changes will be lost.’ If you click the ‘OK’ button,
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you will be taken to the requested screen without saving any of the data in the previous
screen. If you click the ‘Cancel’ button, the prompt will close and you will not be taken to
the requested screen.
Exhibit 3-7 shows a screen capture of the navigation prompt window:
Exhibit 3-7: Navigation Prompt
Exhibit 3-8 shows the screen capture of the navigation tree:
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Exhibit 3-8: Navigation Tree
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3.4.5
Action Bar
The action bar is located at the bottom of each screen. You can perform the following functions
using the action bar:
• Validate: You can click the ‘Validate’ icon ( ) at any stage of completing a Section 8(d)
Health & Safety Data Reporting submission to check for certain types of errors in a
submission. A ‘Section 8(d) Health & Safety Data Reporting Validation’ pop-up window
generates when you click the ‘Validate’ icon ( ). The ‘Section 8(d) Health & Safety Data
Reporting Validation’ pop-up window displays a report of all validation errors relating to a
failed validation. Refer to Section 4 for more information on validating a submission.
The following exhibits Exhibit 3-9, Exhibit 3-10, Exhibit 3-11, and Exhibit 3-12 show the screen
captures for the action bar:
Exhibit 3-9: Action Bar – Validate
• Save: You can click the ‘Save’ icon ( ) at any stage of completing a Section 8(d) Health &
Safety Data Reporting submission. After you click the ‘Save’ icon ( ), the data entered on
the screen will save. The ‘Save’ function does not validate any data entered.
Exhibit 3-10: Action Bar – Save
• Preview: You can click the ‘Preview’ icon ( ) at any stage of completing a Section 8(d)
Health & Safety Data Reporting submission to preview the submission. After you click the
‘Preview’ icon ( ), a watermarked PDF version of the submission will generate.
Exhibit 3-11: Action Bar – Preview
• Submit: You can click the ‘Submit’ icon ( ) to submit the Section 8(d) Health & Safety
Data Reporting submission or amendments after you or an assigned Support have completed
all required sections of the Section 8(d) Health & Safety Data Reporting submission. After
you click the ‘Submit’ icon ( ), the validation process is initiated. Refer to Section 4 for
further instructions on validation errors. You can continue with the submission process only
after clearing all validation errors. Refer to Section 3.5 for more information on submitting a
Section 8(d) Health & Safety Data Reporting submission to EPA via CDX.
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Exhibit 3-12: Action Bar – Submit
• Help Links: You can click any of the ‘Help’ link, located at the bottom of each screen, at
any stage of completing a Section 8(d) Health & Safety Data Reporting submission.
− If you click the ‘CDX Homepage’ link, you will be taken to the CDX Homepage.
− If you click the ‘MyCDX Homepage’ link, you will be taken to the CDX Login.
− If you click the ‘EPA Homepage’ link, you will be taken to the EPA Homepage.
− If you click the ‘Terms and Conditions’ link, you will be taken to the CDX Terms and
Conditions screen.
− If you click the ‘Privacy Health & Safety Data Reporting’ link, you will be taken to the
CDX Privacy and Security Health & Safety Data Reporting screen.
Exhibit 3-13 shows the screen capture of the action bar ‘Help’ links:
Exhibit 3-13: Action Bar – Links
3.4.6
General Submission Information Screen
You can access the ‘General Submission Information’ screen by clicking the ‘Start New
Submission’ button and creating a new passphrase, or by accessing a Section 8(d) Health &
Safety Data Reporting submission that is in progress by clicking the ‘In Progress’ link and
entering the passphrase associated with the selected submission.
The system allows you to edit the submission alias associated with the submission. If you choose
not to edit the submission alias, the field remains populated with a date and time stamp for when
the submission was created.
The following text field is displayed on the ‘General Submission Information’ screen:
• Submission Alias: This field is auto-populated with a date and time stamp and displays on
the ‘Section 8(d) Health & Safety Data’ submission screen within the ‘Submission Alias’
column. This field is editable should you choose to provide your own submission alias.
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Exhibit 3-14 shows the screen capture for the ‘General Submission Information’ screen:
Exhibit 3-14: General Submission Information Screen
Navigation: Click the ‘Next’ button to navigation to the ‘Technical Contact Information’ screen.
You can also access this screen by clicking the ‘Technical Contact Information’ link within the
navigation tree.
3.4.7
Technical Contact Information Screen
You can access the ‘Technical Contact Information’ screen by clicking the ‘Next’ button from
the ‘General Submission Information’ screen or by clicking the ‘Technical Contact Information’
link within the navigation tree.
The ‘Technical Contact Information’ screen provides a ‘This is a submission on behalf of
another company’ checkbox to indicate that you will be submitting on behalf of another
company.
If you are submitting on behalf of another company, check the ‘This is a submission on behalf of
another company’ checkbox. This functionality has been implemented to accommodate a
company that may use an agent or another individual to submit on their behalf. If this checkbox
is checked, the information of the manufacturing or processing establishment is entered into the
‘Submitting on Behalf Of Company’ screen. To claim contact information as Confidential
Business Information (CBI), check the ‘CBI’ checkbox.
• This is a submission on behalf of another company: Check the ‘This is a submission on
behalf of another company’ check box to identify that you are submitting on behalf of
another company.
• Copy CDX Registration: Click the ‘Copy CDX Registration’ button to identify that you are
the technical contact. The system will populate the fields with your contact information
provided during CDX registration.
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• CBI: Check the ‘CBI’ checkbox to claim the ‘Technical Contact Information’ as CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes. If applicable, select the
appropriate prefix. If you click the ‘Copy CDX Registration’ button, the fields populate with
information entered during CDX registration.
• First Name: Enter the technical contact’s first name. If you clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This is a required field.
• Middle Initial: Enter the technical contact’s middle initial. If you clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
• Last Name: Enter the technical contact’s last name. If you clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This is a required field.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes. If applicable, select the
appropriate suffix. If you clicked the ‘Copy CDX Registration’ button, the fields populate
with information entered during CDX registration.
• Company Name: Enter the technical contact’s company name. If you clicked the ‘Copy
CDX Registration’ button, the fields populate with information entered during CDX
registration. This is a required field.
• Phone Number: Enter the technical contact’s daytime phone number; U.S. or international.
If you clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration. This is a required field.
• Ext: Enter the extension to the technical contact’s daytime phone number.
• Email Address: Enter the technical contact’s email address. The email address must follow
the standard email address format: [email protected]. If you clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This is a required field.
• Mailing Address 1: Enter the first line of the technical contact’s mailing address. If you
clicked the ‘Copy CDX Registration’ button, the fields populate with information entered
during CDX registration. This is a required field.
• Mailing Address 2: Enter the second line of the technical contact’s mailing address. If you
clicked the ‘Copy CDX Registration’ button, the fields populate with information entered
during CDX registration.
• City: Enter the city of the technical contact’s mailing address. If you clicked the ‘Copy CDX
Registration’ button, the fields populate with information entered during CDX registration.
This is a required field.
• State: Displays all available states. Enter the state of the technical contact’s mailing address.
If you clicked the ‘Copy CDX Registration’ button, the fields populate with information
entered during CDX registration. This is a required field if the ‘Country’ field is defined as
‘United States.’
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• Postal Code: Enter the postal code of the technical contact’s mailing address. If you clicked
the ‘Copy CDX Registration’ button, the fields populate with information entered during
CDX registration. This is a required field.
• Country: Displays all available countries. Select the country of the technical contact’s
mailing address. If you clicked the ‘Copy CDX Registration’ button, the fields populate with
information entered during CDX registration. This is a required field.
Exhibit 3-15 shows the screen capture of the ‘Technical Contact Information’ screen:
Exhibit 3-15: Technical Contact Information Screen
Navigation: Click the ‘Next’ button to navigate to the ‘Chemical Substance Identity of
Impurities’ screen. You can also access this screen by clicking the ‘Chemical Substance Identity
of Impurities’ link within the navigation tree. If you are submitting on behalf of another
company, click the ‘Next’ button to navigate to the ‘Submitting on Behalf Of Company’ screen.
You can also access this screen by clicking the ‘Submitting on Behalf of Company’ link within
the navigation tree after clicking the ‘Save’ icon located within the bottom action bar.
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3.4.8
Submitting on Behalf Of Company Screen
You can access the ‘Submitting on Behalf of Company’ screen by checking the ‘This is a
submission on behalf of another company’ checkbox and clicking the ‘Next’ button from the
‘Technical Contact Information’ screen. You can also access this screen by clicking the
‘Submitting on Behalf of Company’ link within the navigation tree.
The ‘Submitting on Behalf of Company’ screen presents a list of fields for you to input the
contact information for the manufacturing or processing establishment on whose behalf the
submission is being made.
• CBI: Checking this checkbox will claim the manufacturing or processing establishment
contact for which the submission is being made as CBI.
• Prefix: The ‘Prefix’ drop-down menu displays all optional prefixes and captures the prefix
of the manufacturing or processing establishment contact for which the submission is being
made. If applicable, select the appropriate prefix.
• First Name: Enter the first name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Middle Initial: Enter the middle initial of the manufacturing or processing establishment
contact for which the submission is being made.
• Last Name: Enter the last name of the manufacturing or processing establishment contact
for which the submission is being made. This field is required.
• Suffix: The ‘Suffix’ drop-down menu displays all optional suffixes and captures the suffix
of the manufacturing or processing establishment contact for which the submission is being
made. If applicable, select the appropriate suffix.
• Company Name: Enter the company name of the manufacturing or processing
establishment. This field is required.
• Phone Number: Enter the daytime phone number of the manufacturing or processing
establishment contact for whom the submission is being made, U.S. or international. This
field is required.
• Ext: Enter the extension to the contact’s daytime phone number.
• Email Address: Enter the email address of the manufacturing or processing establishment
contact for which the submission is being made. The email address must follow the
standard email address format: [email protected]. This field is required.
• Mailing Address 1: Enter the first line of the mailing address of the manufacturing or
processing establishment contact. This field is required.
• Mailing Address 2: Enter the second line of the mailing address of the manufacturing or
processing establishment contact.
• City: Enter the city of the mailing address of the manufacturing or processing
establishment contact. This field is required.
• State: Enter the state of the mailing address of the manufacturing or processing
establishment contact. This is a required field if the ‘Country’ field is defined as ‘United
States.’
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• Postal Code: Enter the postal code of the mailing address of the manufacturing or
processing establishment contact. This field is required
• Country: Enter the country of the mailing address of the manufacturing or processing
establishment contact. This field is required.
Exhibit 3-16 shows the screen capture of the ‘Submitting on Behalf of Company’ screen:
Exhibit 3-16: Submitting on Behalf of Company Screen
Navigation: Click the ‘Next’ button to navigate to the ‘Chemical Substance Identity of
Impurities’ screen. You can also access this screen by clicking the ‘Chemical Substance Identity
of Impurities’ link within the navigation tree.
3.4.9
Chemical Substance Identity of Impurities Screen
You can access the ‘Chemical Substance Identity of Impurities’ screen by clicking the ‘Next’
button from the ‘Submitting on Behalf Of Company’ screen, or the ‘Technical Contact
Information’ screen. You can also access this screen by clicking the ‘Chemical Substance
Identity of Impurities’ link within the navigation tree.
The ‘Chemical Substance Identity of Impurities’ screen provides fields for you to identify
impurities or additives known to have been present in the substance or listed mixtures as studied.
To identify chemical impurities you must access the Substance Registry Services (SRS). The
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system leverages the services provided by SRS. To search SRS, click the ‘Search’ icon ( )
within the ‘SRS’ column of the Chemical Substance Identity of Impurities table. Clicking the
‘Search’ icon ( ) generates the SRS pop-up window. You can search for the chemical(s) being
reported by the ‘CASRN,’ ‘CAS Index Name or Synonym,’ ‘Accession Number,’ or ‘Generic
Name.’
• Not Applicable: If the ‘Not Applicable’ checkbox is unchecked and you click the ‘Next’
button, the system will prompt you with an error message indicating a chemical must be
populated by searching for a chemical or to check the ‘Not Applicable’ checkbox.
• Search SRS: Clicking the ‘Search’ icon (
) will generate a ‘Search SRS’ pop-up window.
• Chemical Identifying Number: Displays the chemical identifying number for the specified
chemical substance.
• Chemical Name (descriptor): Displays the chemical name (or descriptor) of the chemical(s)
being reported on.
• Synonym: Displays the chemical synonym(s) identified by the user within the ‘Chemical
Not Found in Substance Registry Services’ window.
• CBI: Displays the CBI status of the identified chemical substance by displaying either a ‘Y’
or an ‘N.’ A chemical substance retrieved via CASRN or CA Index Number or Other
Synonym cannot be claimed as CBI. Only chemical substances retrieved via accession
number or generic name, or chemical substances not found within the SRS search can be
claimed as CBI. A CBI checkbox will populate the table allowing you to select the applicable
chemical as CBI.
• Actions: Click the ‘Delete’ icon ( ) to remove the chemical within the specific row.
Exhibit 3-17 shows the screen capture of the ‘Chemical Substance Identity of Impurities’ screen:
Exhibit 3-17: Chemical Substance Identity of Impurities Screen
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Navigation: Click the ‘Next’ button to navigate to the ‘Study Identification’ screen. You can
also access this screen by clicking the ‘Study Identification’ link within the navigation tree.
3.4.9.1
Search Substance Registry Services
To access SRS, click the ‘Search’ icon ( ). Clicking the ‘Search’ icon ( ) generates the
‘Search SRS’ pop-up window. You can search for the chemical(s) being reported by the
‘CASRN,’ ‘CA Index Name or Other Synonym,’ ‘Accession Number,’ or ‘Generic Name.’ After
you have searched, selected a chemical, and clicked the ‘OK’ button, the selected chemical
information will populate the Chemical Substance Identity of Impurities table. If the chemical is
not listed on the public TSCA Inventory list, you may claim the chemical as CBI, once the
chemical is displayed on the Chemical Substance Identity of Impurities table. See Section 3.4.9.2
below if you do not know the CAS or Accession Number.
• CASRN: Enter the CASRN of the chemical.
• CA Index Name or Other Synonym: Enter the CA Index Name or Other Synonym.
Displays the following search options: ‘Contains,’ ‘Begins With,’ and ‘Matches Exactly.’
• Accession Number: Enter the accession number of the chemical. Displays the following
search options: ‘Contains,’ ‘Begins With,’ and ‘Matches Exactly.’
• Generic Name: Enter the generic name. Displays the following search options: ‘Contains,’
‘Begins With,’ and ‘Matches Exactly.’
Exhibit 3-18 shows the screen capture for the ‘Search Substance Registry Services’ pop-up
window:
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Exhibit 3-18: Search Substance Registry Services Pop-Up Window
Navigation: Clicking the ‘Search’ button will generate search results. The ‘OK,’ ‘Cancel,’ and
‘X’ buttons will close the ‘Search SRS’ pop-up window.
3.4.9.2
Chemical Not Found in Substance Registry Services
You can access the ‘Chemical Not Found in Substance Registry Services’ screen by entering
known information into the SRS window and performing a search. If there are no results, a
message will be returned stating ‘There were no results returned.’ If you are sure the chemical
does not exist in SRS, please click the ‘Create New Chemical’ button to enter the chemical
information. Clicking the ‘Create New Chemical’ button on the ‘Search Substance Registry
Services’ screen takes you to the ‘Chemical Not Found in Substance Registry Services’ screen.
Click the ‘Cancel’ button to go back to the ‘Search Substance Registry Services’ screen. When
entering information into the ‘Chemical Not Found in Substance Registry Services’ screen at
least one of the following four fields is required; ‘Accession Number,’ ‘CASRN,’
‘Premanufacture Notice (PMN) Number,’ or ‘International Union of Pure and Applied
Chemistry (IUPAC) Name’
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If you do not know the accession number, CASRN, PMN number, or IUPAC name, check the
‘Unknown’ checkbox. Once you check the ‘Unknown’ checkbox, the above-mentioned fields are
disabled and you are only required to enter a chemical name (or descriptor).
• Unknown: Checking the ‘Unknown’ checkbox disables the ‘Accession Number,’
‘CASRN,’ ‘PMN Number,’ and ‘IUPAC Name’ fields and requires you to enter the
chemical name in the ‘Chemical Name (descriptor)’ field.
• Accession Number: If known, enter the accession number of the chemical.
• CASRN: If known, enter the CASRN of the chemical.
• PMN Number: If known, enter the PMN number of the chemical.
• IUPAC Name: If known, enter the IUPAC name of the chemical.
• Chemical Name (descriptor): Enter the chemical name/descriptor of the chemical being
reported. This is a required field when the ‘Unknown’ checkbox is checked.
Exhibit 3-19 shows the screen capture for the ‘Chemical Not Found in Substance Registry
Services’ pop-up window:
Exhibit 3-19: Chemical Not Found in Substance Registry Services Pop-Up Window
Navigation: Clicking the ‘OK,’ ‘Cancel,’ and ‘X’ buttons will close the ‘Chemical Not Found In
SRS’ pop-up window. Click the ‘OK’ button to populate the table on the ‘Chemical Substance
Identity of Impurities’ screen. Click the ‘Cancel’ button to navigate back to the ‘Search
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Substance Registry Services’ pop-up window. Click the ‘X’ icon to close the pop-up window
and your information will not be saved.
3.4.10
Study Identification Screen
You can navigate to the ‘Study Identification’ screen by clicking the ‘Next’ button from the
‘Chemical Substance Identity of Impurities’ screen. You can also access this screen by clicking
the ‘Study Identification’ link within the navigation tree.
The ‘Study Identification’ screen provides checkboxes for you to identify the study type(s) being
submitted. To identify the submission study type, check each option that applies to the Section
8(d) Health & Safety Data Reporting submission. The following checkbox options are displayed
within the ‘Study Identification’ screen:
• Not Applicable: Check the ‘Not Applicable’ checkbox to claim that there are no applicable
studies. A pop-up message displays to confirm this selection.
• Full Study Report: Check the ‘Full Study Report’ checkbox to indicate the desired
submission study type.
• Initiated Studies: Check the ‘Initiated Studies’ checkbox to indicate the desired submission
study type.
• Ongoing Studies: Check the ‘Ongoing Studies’ checkbox to indicate the desired submission
study type.
• Robust Summary: Check the ‘Robust Summary’ checkbox to indicate the desired
submission study type.
• Studies Which are Known but are without Possession of Copies: Check the ‘Studies
Which are Known but are without Possession of Copies’ checkbox to indicate the desired
submission study type.
• Studies Previously Sent to Federal Agencies without Confidentiality Claims: Check the
‘Studies Previously Sent to Federal Agencies without Confidentiality Claims’ checkbox to
indicate the desired submission study type.
The following checkbox options are only available when you are amending a previous
submission. Please refer to Section 3.5 for additional information:
• EPA Request for Submission of Further Information
− Underlying Data: Check the ‘Underlying Data’ checkbox to indicate the desired
submission study type.
− Preliminary Report of Ongoing Studies: Check the ‘Preliminary Report of Ongoing
Studies’ checkbox to indicate the desired submission study type.
− Copies of Studies: Check the ‘Copies of Studies’ checkbox to indicate the desired
submission study type.
Once you have checked all appropriate submission study types and saved your selections by
either clicking the ‘Save,’ ‘Previous,’ or ‘Next’ buttons, the navigation tree is populated with the
selected study type screen titles.
Each study type is dynamically related to specific metadata and each study type chosen from the
‘Study Identification’ screen populates within the navigation tree as a new screen. Only the study
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type options you select are displayed within the navigation tree. You can navigate to each
selected study type screen by clicking the desired link within the navigation tree or navigating
using the ‘Previous’ and ‘Next’ buttons. Each study type screen will display all entered
information as well as all attached documentation.
Exhibit 3-20 shows the screen capture for the ‘Study Identification’ screen:
Exhibit 3-20: Study Identification Screen
Exhibit 3-21 shows the screen capture for the ‘Study Identification’ screen:
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Exhibit 3-21: Study Identification Screen for an Amendment
Navigation: Check the appropriate study type checkboxes for the studies you wish to submit and
click the ‘Next’ button to navigate to the next screen from the ‘Study Identification’ screen. The
screen following the ‘Study Identification’ screen depends on the item(s) selected. If you are not
submitting any of the indicated study types, check the ‘Not Applicable’ checkbox and click the
‘Next’ button to navigate to the ‘Submitter Request’ screen.
3.4.11
Full Study Report Screen
You can access the ‘Full Study Report’ screen by checking the ‘Full Study Report’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Full Study Report’ link in the navigation tree if you previously checked the ‘Full
Study Report’ checkbox.
To attach ‘Full Study Report’ documentation, click the ‘Add Document’ button displayed on the
‘Full Study Report’ screen. Clicking the ‘Add Document’ button generates the ‘Full Study
Report’ pop-up window for you to upload all desired documentation. You can browse for a
document from your hard drive and attach one document at a time. If you claim a document as
CBI, then a sanitized copy of the document must be attached. If you fail to attach a sanitized
copy of the document, the system will displays an error.
To attach multiple documents, click the ‘Add Document’ button on the ‘Full Study Report’
screen. If you claim the document as CBI then a sanitized file will need to be uploaded. Clicking
the ‘Browse’ button will generate a pop-up window allowing you to attach a document from
your hard drive. You can delete unwanted attached documents by clicking the delete icon located
within the ‘Action’ column of the full study report table. To attach a replacement document for a
document that was previously attached, click the file name link for the desired document under
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the ‘File Name’ column. Once you click the file name link of the desired document, the
attachment pop-up window generates for you to attach a new document. Attaching a new
document will overwrite the existing document. The changes will commit once you click the
‘OK’ button.
After all required information has been completed; click the ‘Next’ button to navigate to the next
study type screen that you identified on the ‘Study Identification’ screen. If you have not
indicated an additional study type you will be taken to the ‘Submitter Requests’ screen.
Exhibit 3-22 shows the screen capture of the ‘Full Study Report’ screen:
Exhibit 3-22: Full Study Report Screen
Navigation: Click the ‘Next’ button to navigate to the next screen. The next screen is dependent
upon your selection of submission types on the ‘Study Identification’ screen. If you have not
selected another study type you will be taken to the ‘Submitter Requests’ screen upon clicking
the ‘Next’ button.
The ‘Document Management’ pop-up window allows you to browse for a document from your
hard drive and attach one document at a time. You must attach at least one document. Clicking
the ‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select the
document you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then
a sanitized copy of the document must be attached. To save the attached document to the
‘Document Management’ screen, click the ‘OK’ button within the ‘Document Management’
pop-up window.
• CBI: Checking the ‘CBI’ checkbox will claim the uploaded document as CBI and
generate a sanitized document upload field.
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• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the CBI checkbox is
checked. Clicking the ‘Browse’ button will generate the ‘File Upload’ window for you to
search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. The drop-down menu displays
the following options: ‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical
Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Document Management’ pop-up window. If you have multiple documents that
share the same effects and/or endpoints, you must upload each individual document separately
and select values from the drop-down menus.
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Exhibit 3-23 shows the screen capture of the ‘Full Study Report’ pop-up window:
Exhibit 3-23: Full Study Report Pop-Up Window
Navigation: Click the ‘OK’ button to close the ‘Full Study Report’ pop-up window and save the
attached documents to the full study report table. Click the ‘Cancel’ or ‘X’ button to close the
pop-up window and no information will be saved.
3.4.12
Initiated Studies Screen
You can access the ‘Initiated Studies’ screen by checking the ‘Initiated Studies’ checkbox on the
‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen by
clicking the ‘Initiated Studies’ link within the navigation tree.
The ‘Initiated Studies’ screen provides ‘Add Documents’ and ‘Add Studies’ radio buttons.
Selecting the ‘Add Documents’ radio button option will generate the ‘Add Document’ button
and the initiated studies table. Clicking the ‘Add Document’ button generates the ‘Initiated
Studies’ pop-up window for you to upload documentation pertaining to the initiated studies. You
can claim the uploaded document as CBI by checking the ‘CBI’ checkbox within the ‘Initiated
Studies’ pop-up window. A sanitized version of the document is required if you claim the
attached document as CBI.
If you select the ‘Add Documents’ radio button option, the system generates an ‘Add Document’
button. To attach multiple documents, click the ‘Add Document’ button from the ‘Initiated
Studies’ screen. You can delete unwanted attached documents by clicking the ‘Delete’ icon
located within the ‘Action’ column of the initiate’s studies table. To attach a replacement
document for a document that was previously attached, click the file name link for the desired
document under the ‘File Name’ column. Once you click the file name link of the desired
document, the attachment pop-up window generates for you to attach a new document. Attaching
a new document will overwrite the existing document. The changes will commit once you click
the ‘OK’ button.
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If you select the ‘Add Studies’ radio button, the system generates an ‘Add Study’ button.
Clicking the ‘Add Study’ button generates a field set to enter all required study information. You
are required to identify the beginning date of the study, the purpose of the study, types of data to
be collected, the anticipated date of completion, and the name and address of the laboratory
conducting the study. This information must accompany each listed entry.
The system provides the following text fields for you to enter information:
• Add Documents: Select the radio button to attach an initiated studies document.
• Add Studies: Select the radio button to enter initiated studies information.
• Add Study: Click the button to generate the study expandable/collapsible field set.
• Study Title: Enter the title of the study. This is a required field.
• Study Start Date: Enter the start date of the study. You can use the calendar widget to enter
a date. This is a required field.
• Study End Date: Enter the end date of the study. You can use the calendar widget to enter a
date. This is a required field.
• Study Purpose: Enter the purpose of the study. This is a required field.
• Data to be Collected: Enter the type data that will be collected throughout the duration of
the specified study. This is a required field.
• CBI: Check the ‘CBI’ checkbox to claim the information of the laboratory conducting the
study as confidential.
• Laboratory Name: Enter the name of the laboratory conducting the study. This is a required
field.
• Mailing Address 1: Enter the first line of the mailing address of the laboratory conducting
the study. This is a required field.
• Mailing Address 2: Enter the second line of the mailing address of the laboratory
conducting the study.
• City: Enter the city of the mailing address of the laboratory conducting the study. This is a
required field.
• State: Select the state of the mailing address of the laboratory conducting the study. The
‘State’ field is required when ‘United States’ is selected from the ‘Country’ drop-down
menu.
• Postal Code: Enter the postal code of the mailing address of the laboratory conducting the
study. This is a required field.
• Country: Select the country of the mailing address of the laboratory conducting the study.
This is a required field.
The system allows you to associate multiple studies to a single laboratory. Once you enter the
laboratory contact information and save the entered data within the field set by clicking the
‘Save’ button, that laboratory contact information is saved to the ‘Create a new laboratory or
select an existing one from the drop-down’ menu. Click the ‘Delete’ icon ( ) to delete any
unwanted studies. The ‘Delete’ icon ( ) is located in the top right corner of the specified field
set. Clicking the ‘Expand All’ link will expand all field sets. Likewise, clicking the ‘Collapse
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All’ link will collapse all field sets. To expand or collapse a field set individually, click the
toggle arrow located in the top left corner of the specified field set.
Exhibit 3-24 shows the screen capture of the ‘Initiated Studies’ screen when you select the ‘Add
Document’ radio button:
Exhibit 3-24: Initiated Studies Screen (Add Document)
Navigation: Click the ‘Next’ button to navigate to the next screen. The next screen is dependent
upon your selection of submission types on the ‘Study Identification’ screen. If no other studies
were selected you will be taken to the ‘Submitter Requests’ screen upon clicking the ‘Next’
button.
The ‘Document Management’ pop-up window allows you to browse for a document from your
hard drive and attach one document at a time. You must attach one document. Clicking the
‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select the document
you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then a sanitized
copy of the document must be attached. To save the attached document to the ‘Initiated Studies’
screen, click the ‘OK’ button within the ‘Initiates Studies’ pop-up window.
• File Name: Displays the file name of the initiated studies document.
• CBI: Indicates the CBI status of the initiated studies document by displaying either a ‘Y’
or an ‘N.’
• Actions: Click the ‘Delete’ icon (
displays a confirmation prompt.
) to remove a document from the system. The system
• CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field.
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• Document Upload: Click the ‘Browse’ button to generate the ‘File Upload’ window for
you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the CBI checkbox is
selected. Clicking the ‘Browse’ button will generate the ‘File Upload’ window for you to
search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. This drop-down menu displays
the following options: ‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical
Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values found within each of the drop-down menus on
the ‘Initiated Studies’ pop-up window. If you have multiple documents that share the same
effects and/or endpoints, you must upload each individual document separately and select values
from the drop-down menus.
Exhibit 3-25 shows the screen capture of the ‘Initiated Studies’ pop-up window:
Exhibit 3-25: Initiated Studies Pop-Up Window
Navigation: Click the ‘OK’ button to close the ‘Initiated Studies’ pop-up window and save the
attached document to the initiated studies table. Clicking the ‘Cancel’ or ‘X’ button will close the
‘Initiated Studies’ pop-up window but no entered information will be saved or displayed on the
‘Initiated Studies’ screen.
Exhibit 3-26 shows the screen capture of the ‘Initiated Studies’ screen when the ‘Add Studies’
radio button is selected:
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
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October 22, 2013
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Exhibit 3-26: Initiated Studies Screen (Add Study)
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Navigation: Click the ‘Next’ button to proceed to the next screen. The next screen is dependent
upon the selections you made on the ‘Study Identification’ screen. If no other studies were
selected, you will navigate to the ‘Submitter Requests’ screen upon clicking the ‘Next’ button.
3.4.13
Ongoing Studies Screen
You can access the ‘Ongoing Studies’ screen by checking the ‘Ongoing Studies’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Ongoing Studies’ link within the navigation tree.
The ‘Ongoing Studies’ screen provides you with ‘Add Documents’ and ‘Add Studies’ radio
buttons. Selecting the ‘Add Documents’ radio button generates the ‘Add Document’ button and
the ongoing studies table. Clicking the ‘Add Document’ button generates the ‘Ongoing Studies’
pop-up window for you to upload documentation relating to the reported ongoing studies. You
can delete unwanted attached documents by clicking the ‘Delete’ icon located within the
‘Action’ column of the Ongoing Studies table. To attach a replacement document for one that
was previously attached, click the file name link for the desired document under the ‘File Name’
column. Once you click the file name link of the desired document, the attachment pop-up
window generates for you to attach a new document. Attaching a new document will overwrite
the existing document. The changes will commit once you click the ‘OK’ button.
If you select the ‘Add Studies’ radio button, the system generates the ‘Add Study’ button.
Clicking the ‘Add Study’ button generates a field set to enter all required study information. You
are required to identify the beginning date of the study, the purpose of the study, types of data to
be collected, the anticipated date of completion, and the name and address of the laboratory
conducting the study. This information must accompany each listed entry.
The system provides the following text fields to complete:
• Add Documents: Select the radio button to attach an ongoing studies document. At least one
radio button must be selected.
• Add Studies: Select the radio button to enter ongoing studies information. At least one radio
button must be selected.
• Add Study: Click the button to generate the study expandable/collapsible field set.
• Study Title: Enter the title of the study. This is a required field.
• Study Start Date: Enter the start date of the study. You can use the calendar widget to enter
a date. This is a required field.
• Study End Date: Enter the end date of the study. You can use the calendar widget to enter a
date. This is a required field.
• Study Purpose: Enter the purpose of the study. This is a required field.
• Data to be Collected: Enter the type of data to be collected throughout the duration of the
specified study. This is a required field.
• CBI: Check the ‘CBI’ checkbox to claim the information of the laboratory conducting the
study as confidential.
• Laboratory Name: Enter the name of the laboratory conducting the study. This is a required
field.
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• Mailing Address 1: Enter the first line of the mailing address of the laboratory conducting
the study. This is a required field.
• Mailing Address 2: Enter the second line of the mailing address of the laboratory
conducting the study.
• City: Enter the city of the mailing address of the laboratory conducting the study. This is a
required field.
• State: Select the state of the mailing address of the laboratory conducting the study. This is a
require field if the Country field is set to the ‘United States.’
• Postal Code: Enter the postal code of the mailing address of the laboratory conducting the
study. This is a required field.
• Country: Select the country of the mailing address of the laboratory conducting the study.
This is a required field.
The system provides functionality for you to associate multiple studies to a single laboratory.
Once you enter the laboratory contact information within the field set by clicking the ‘Save’
button, that contact information is saved to the ‘Create a new laboratory or select an existing one
from the drop-down’ menu. You can click the delete icon to delete any unwanted studies which
are located in the top right corner of the specified field set. Clicking the ‘Expand All’ link will
expand all field sets. Likewise, clicking the ‘Collapse All’ link will collapse all field sets. To
expand or collapse a field set individually, click the toggle arrow located in the top left corner of
the specified field set.
After all required information has been entered into the ‘Ongoing Studies’ screen, you can
navigate to the next study identified on the ‘Study Identification’ screen by clicking the ‘Next’
button or by clicking the next study link within the navigation tree.
Exhibit 3-27 shows the screen capture of the ‘Ongoing Studies’ screen when you select the ‘Add
Documents’ radio button:
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Exhibit 3-27: Ongoing Studies Screen (Add Document)
The ‘Ongoing Studies’ pop-up window allows you to browse for a document from your hard
drive and attach one document at a time. You must attach one document. Clicking the ‘Browse’
button will generate the ‘File Upload’ window on your hard drive. Select the document you wish
to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then a sanitized copy of
the document must be attached. To save the attached document to the ‘Ongoing Studies’ screen,
click the ‘OK’ button within the ‘Ongoing Studies’ pop-up window.
• CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the ‘CBI’ checkbox
is checked. Clicking the ‘Browse’ button will generate the ‘File Upload’ window for you
to search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. The drop-down menu displays
the following options: ‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical
Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Ongoing Studies’ pop-up window. If you have multiple documents that share the
same effects and/or endpoints, you must upload each individual document separately and select
values from the drop-down menus.
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
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Exhibit 3-28 shows the screen capture of the ‘Ongoing Studies’ pop-up window:
Exhibit 3-28: Ongoing Studies Pop-Up Window
Exhibit 3-29 shows the screen capture of the ‘Ongoing Studies’ Screen when you select the ‘Add
Studies’ radio button:
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Exhibit 3-29: Ongoing Studies Screen (Add Study)
Navigation: Once all required information is entered, click the ‘Next’ button to navigate to the
next submission type screen. The next screen is dependent upon the selections you made on the
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‘Study Identification’ screen. If no other study types were identified on the ‘Study Identification
screen,’ click the ‘Next’ button to navigate to the ‘Submitter Request’ screen.
3.4.14
Robust Summary Screen
You can access the ‘Robust Summary’ screen by checking the ‘Robust Summary’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Robust Summary’ link within the navigation tree.
You can upload robust summary documentation by clicking the ‘Add Document’ button on the
‘Robust Summary’ screen. At least one document must be uploaded. Clicking the ‘Add
Document’ button generates the ‘Robust Summary’ pop-up window for you to upload
documents. To add additional documents, click the ‘Add Document’ button on the ‘Robust
Summary’ screen. You can delete unwanted attached documents by clicking the ‘Delete’ icon
located in the ‘Action’ column of the Robust Summary table. To attach a replacement document
for a document that was previously attached, click the file name link for the desired document
under the ‘File Name’ column. Once you click the file name link of the desired document, the
attachment pop-up window generates for you to attach a new document. Attaching a new
document will overwrite the existing document. The changes will commit once you click the
‘OK’ button and display within the table the file name, CBI claim, and possible action.
After all desired documents have been attached, click the ‘Next’ button to navigate to the next
study type identified on the ‘Study Identification’ screen or the ‘Submitter Request’ screen if no
other study types were identified.
Exhibit 3-30 shows the screen capture of the ‘Robust Summary’ screen:
Exhibit 3-30: Robust Summary Screen
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Navigation: Once all required documentation has been attached, click the ‘Next’ button to
navigate to the next submission type screen. The next screen is dependent upon the selections
made on the ‘Study Identification’ screen. If no other study types were identified on the ‘Study
Identification’ screen, you will be taken to the ‘Submitter Request’ screen upon clicking the
‘Next’ button.
The ‘Robust Summary’ pop-up window allows you to browse for a document from your hard
drive and attach one document at a time. You must attach one document. Clicking the ‘Browse’
button will generate the ‘File Upload’ window on your hard drive. Select the document you wish
to attach and click the ‘Open’ button. To save the attached document to the ‘Robust Summary’
screen, click the ‘OK’ button within the ‘Robust Summary’ pop-up window.
• File Name: Displays the file name and file extension of a robust summary document
attached on the ‘Robust Summary’ pop-up window.
• Actions: Click the ‘Delete’ icon ( ) to remove the attached robust summary document. A
confirmation message displays to confirm removal of the document.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. This drop-down menu displays
the following options: ‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical
Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values displayed within each of the drop-down menus
on the ‘Robust Summary’ pop-up window. If you have multiple documents that share the same
effects and/or endpoints, you must upload each individual document separately and select values
from the drop-down menus.
Exhibit 3-31 shows the screen capture of the ‘Robust Summary’ pop-up window:
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
October 22, 2013
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Exhibit 3-31: Robust Summary Pop-Up Window
Navigation: Once all required documentation has been attached, click the ‘Next’ button to
navigate to the next submission type screen. The next screen is dependent upon the selections
made on the ‘Study Identification’ screen. If no other study types were identified on the ‘Study
Identification’ screen, you will be taken to the ‘Submitter Request’ screen upon clicking the
‘Next’ button.
3.4.15
Studies Which Are Known But Without Possession of Copies Screen
You can access the ‘Studies Which are Known but without Possession of Copies’ screen by
checking the ‘Studies Which are Known but without Possession of Copies’ checkbox on the
‘Study Identification’ screen and clicking the ‘Next’ button if no other study types were selected.
You can also access this screen by clicking the ‘Studies Which are Known but without
Possession of Copies’ link within the navigation tree.
The ‘Studies Which Are Known but Without Possession of Copies’ screen provides you with
‘Add Documents’ and ‘Add Studies’ radio buttons. Selecting the ‘Add Documents’ radio button
generates the ‘Add Document’ button and the ‘Studies which are known but Without Possession
of Copies’ table. Clicking the ‘Add Document’ button generates the ‘Studies which are known
but Without Possession of Copies’ pop-up window for you to upload related documentation. To
add additional documents, click the ‘Add Document’ button on the ‘Studies Which Are Known
but without Possession of Copies’ screen. You can delete unwanted attached documents by
clicking the ‘Delete’ icon located in the ‘Action’ column of the Studies Which Are known but
without Possession of Copies table. To attach a replacement document for a document that was
previously attached, click the file name link for the desired document under the ‘File Name’
column. Once you click the file name link of the desired document, the attachment pop-up
window generates for you to attach a new document. Attaching a new document will overwrite
the existing document. The changes will commit once you click the ‘OK’ button.
If you select the ‘Add Studies’ radio button, the system generates the ‘Add Study’ button.
Clicking the ‘Add Study’ button generates a field set to enter required study information. You
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are required to identify the study title, and the name and address of the contact possessing a copy
of the study. This information must accompany each listed entry.
The system provides the following text fields to complete:
• Add Documents: Select the radio button to attach studies which are known but without
possession of copies documents. At least one radio button must be selected.
• Add Studies: Select the radio button to enter information regarding studies, which are
known, but without possession of copies. At least one radio button must be selected.
• Add Study: Click the button to generate the study expandable/collapsible field set.
• File Name: Displays the file name and file extension of the document attached on the
‘Studies Which are Known but Without Possession of Copies’ pop-up window.
• CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’
• Actions: Click the ‘Delete’ icon ( ) to remove the attachment. A warning message displays
to confirm the removal of the attachment.
• Study Title: Enter the title of the study. This field is required.
• CBI: Check the ‘CBI’ checkbox to claim the information of the contact possessing a copy of
the study as confidential.
• Prefix: If applicable, select the prefix of the contact possessing a copy of the study.
• First Name: Enter the first name of the contact possessing a copy of the indicated study.
This field is required.
• Last Name: Enter the last name of the contact possessing a copy of the indicated study. This
field is required.
• Suffix: If applicable, select the suffix of the contact possessing a copy of the indicated study.
• Phone Number: Enter the phone number of the contact possessing a copy of the indicated
study. This field is required.
• Ext: Enter the extension to the phone number of the contact possessing a copy of the
indicated study.
• Email Address: Enter the email address of the contact possessing a copy of the indicated
study. The email address must follow the standard email address format: [email protected].
This field is required.
• Mailing Address 1: Enter the first line of the mailing address of the laboratory possessing a
copy of the indicated study. This field is required.
• Mailing Address 2: Enter the second line of the mailing address of the laboratory possessing
a copy of the indicated study.
• City: Enter the city of the mailing address of the contact possessing a copy of the indicated
study. This field is required.
• State: Select the state of the mailing address of the contact possessing a copy of the indicated
study. This field is required if ‘United States’ is selected as the country.
• Postal Code: Enter the postal code of the mailing address of the contact possessing a copy of
the indicated study. This field is required.
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• Country: Select the country of the mailing address of the contact possessing a copy of the
indicated study. This field is required.
The system allows you to associate multiple studies to a single contact. Once you enter the
contact information and save the entered information within the field set by clicking the ‘Save’
button, that contact information is saved to the ‘Create a new contact or select an existing one
from the drop-down’ menu. Click the ‘Save’ button to navigate to the ‘Studies Which Are
Known but without Possession of Copies’ screen where all the added studies would be displayed.
You can click the ‘Delete’ icon to delete any unwanted studies you have previously entered by
clicking the ‘Delete’ icon which is located in the top right corner of the specified field set.
Clicking the ‘Expand All’ link will expand all field sets. Likewise, clicking the ‘Collapse All’
link will collapse all field sets. To expand or collapse all field set individually, click the toggle
arrow located in the top left corner of the specified field set.
After all information has been entered into the ‘Studies Which Are Known but without
Possession of Copies’ screen, navigate to the next study identified on the ‘Study Identification’
screen by clicking the ‘Next’ button or by clicking the next study link within the navigation tree.
If no additional study types were selected, click the ‘Next’ button to navigate to the ‘Submitter
Request’ screen.
Exhibit 3-32 shows the screen capture of the ‘Studies Which Are Known but without Possession
of Copies’ screen:
Exhibit 3-32: Studies Which Are Known but without Possession of Copies (Add
Document)
The ‘Studies Which are Known but Without Possession of Copies’ pop-up window allows you to
browse for a document from your hard drive and attach one document at a time. You must attach
one document. Clicking the ‘Browse’ button will generate the ‘File Upload’ window on your
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
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hard drive. Select the document you wish to attach and click the ‘Open’ button. If a document is
marked as ‘CBI’ then a sanitized copy of the document must be attached. To save the attached
document to the ‘Studies Which are Known but Without Possession of Copies’ screen, click the
‘OK’ button within the ‘Studies Which are Known but Without Possession of Copies’ pop-up
window.
• CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the ‘CBI’ checkbox
is checked. Clicking the ‘Browse’ button will generate the ‘File Upload’ window for you
to search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. This drop-down menu displays
the following options: ‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical
Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values displayed within each of the drop-down menus
on the ‘Studies Which are Known but Without Possession of Copies’ pop-up window. If you
have multiple documents that share the same effects and/or endpoints, you must upload each
individual document separately and select values from the drop-down menus.
Exhibit 3-33 shows the screen capture of the ‘Studies Which Are Known but without Possession
of Copies’ pop-up window:
OPPT MTS Section 8(d) Health & Safety Data Reporting User Guide
Primary Authorized Official
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Exhibit 3-33: Studies Which Are Known but without Possession of Copies Pop-Up
Window
Exhibit 3-34 shows the screen capture of the ‘Studies Which Are Known but without Possession
of Copies’ screen when you select the ‘Add Studies’ radio button:
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Primary Authorized Official
October 22, 2013
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Exhibit 3-34: Studies Which Are Known but without Possession of Copies Screen (Add
Study)
Navigation: Once all required information is entered, click the ‘Next’ button to proceed to the
next submission study type screen. The next screen is dependent upon the selections you made
on the ‘Study Identification’ screen. If no other study types were identified on the ‘Study
Identification’ screen, click the ‘Next’ button to navigate to the ‘Submitter Request’ screen.
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3.4.16 Studies Previously Sent to Federal Agencies without Confidentiality Claims
Screen
You can access the ‘Studies Previously Sent To Federal Agencies Without Confidentiality
Claims’ screen by checking the ‘Studies Previously Sent To Federal Agencies Without
Confidentiality Claims’ checkbox on the ‘Study Identification’ screen and clicking the ‘Next’
button. You can also access this screen by clicking the ‘Studies Previously Sent To Federal
Agencies Without Confidentiality Claims’ link within the navigation tree.
The ‘Studies Previously Sent To Federal Agencies Without Confidentiality Claims’ screen
provides you with ‘Add Documents’ and ‘Add Studies’ radio buttons. Selecting the ‘Add
Documents’ radio button generates the ‘Add Document’ button and the studies previously sent to
federal agencies without confidentiality claims table. Clicking the ’Add Document’ button
generates the ‘Studies Previously Sent To Federal Agencies Without Confidentiality Claims’
pop-up window for you to upload associated documentation. To add additional documents, click
the ‘Add Document’ button as needed from the ‘Studies Previously Sent To Federal Agencies
Without Confidentiality Claims’ screen. You can delete unwanted attached documents by
clicking the ‘Delete’ icon within the ‘Actions’ column of the studies previously sent to federal
agencies without confidentiality claims table. To attach a replacement document for a document
that was previously attached, click the file name link for the desired document under the ‘File
Name’ column. Once you click the file name link of the desired document, the attachment popup window generates for you to attach a new document. Attaching a new document will
overwrite the existing document. The changes will commit once you click the ‘OK’ button.
If you click the ‘Add Studies’ radio button, the system generates the ‘Add Study’ button.
Clicking the ‘Add Study’ button generates a field set where you can enter required study
information. You are required to identify the study title, the agency in which the study was sent,
and the name and address of the contact possessing a copy of the indicated study. This
information must accompany each listed entry.
The system provides the following text fields to complete:
• Add Documents: Select the radio button to attach a studies previously sent to federal
agencies without confidentiality claims document. One radio button must be selected.
• Add Studies: Select the radio button to enter studies previously sent to federal agencies
without confidentiality claims information. One radio button must be selected.
• Add Study: Click the button to generate the study expandable/collapsible field set.
• Study Title: Enter the title of the study. This is a required field.
• Study Submission Date: Enter the submission date of the study. You may use the calendar
widget to help find a date. This is a required field.
• Agency: Select an agency from the drop down menu. This is a required field.
• CBI: Check the ‘CBI’ checkbox to claim the information of the contact possessing a copy of
the study as confidential.
• Prefix: If applicable, select the prefix of the contact possessing a copy of the study.
• First Name: Enter the first name of the contact possessing a copy of the study. This is a
required field.
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• Last Name: Enter the last name of the contact possessing a copy of the study. This is a
required field.
• Suffix: If applicable, select the suffix of the contact possessing a copy of the study.
• Phone Number: Enter the phone number of the contact possessing a copy of the study. This
is a required field.
• Ext: Enter the extension to the phone number of the contact possessing a copy of the study.
• Email Address: Enter the email address of the contact possessing a copy of the study. The
email address must follow the standard email address format: [email protected]. This is a
required field.
• Mailing Address 1: Enter the first line of the mailing address of the contact possessing a
copy of the study. This is a required field.
• Mailing Address 2: Enter the second line of the mailing address of the contact possessing a
copy of the study.
• City: Enter the city of the mailing address of the contact possessing a copy of the study. This
is a required field.
• State: Select the state of the mailing address of the contact possessing a copy of the study.
This is a required field if ‘United States’ is selected as the country.
• Postal Code: Enter the postal code of the mailing address of the contact possessing a copy of
the study. This is a required field.
• Country: Select the country of the mailing address of the contact possessing a copy of the
study. This is a required field.
The system provides functionality for you to associate multiple studies to a single contact. Once
you enter the contact information and save the entered data within the field set by clicking the
‘Save’ button, that contact information is saved to the ‘Create a new contact or select an existing
one from the drop-down’ menu. You can delete any unwanted studies by clicking the ‘Delete’
icon, which is located in the top right corner of the specified field set. Clicking the ‘Expand All’
link will expand all field sets. Likewise, clicking the ‘Collapse All’ link will collapse all field
sets. To expand or collapse a field set individually, click the toggle arrow located in the top left
corner of the specified field set.
After all required information has been entered into the ‘Studies Previously Sent To Federal
Agencies Without Confidentiality Claims’ screen, you are ready to submit. If any information
has been claimed CBI, you will be required to complete substantiation before initiating the
submission process.
Exhibit 3-35 shows the screen capture of the ‘Studies Previously Sent To Federal Agencies
Without Confidentiality Claims’ screen:
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Exhibit 3-35: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Screen (Add Document)
The ‘Studies Previously Sent to Federal Agencies Without Confidentiality Claims’ pop-up
window allows you to browse for a document from your hard drive and attach one document at a
time. You must attach at least one document. Clicking the ‘Browse’ button will generate the
‘File Upload’ window on your hard drive. Select the document you wish to attach and click the
‘Open’ button. If a document is marked as ‘CBI’ then a sanitized copy of the document must be
attached. To save the attached document to the ‘Studies Previously Sent to Federal Agencies
Without Confidentiality Claims’ screen, click the ‘OK’ button within the ‘Studies Previously
Sent to Federal Agencies Without Confidentiality Claims’ pop-up window.
• File Name: Displays the file name and file extension of a document attached on the
‘Studies Previously Sent to Federal Agencies Without Confidentiality Claims’ pop-up
window.
• CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’
• Actions: Click the ‘Delete’ icon ( ) to remove an unwanted document. A message
displays to confirm removal of the document.
• CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the ‘CBI’ checkbox
is checked. Clicking the ‘Browse’ button will generate the ‘File Upload’ window for you
to search for a particular file on your hard drive.
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• Effects: Select the effect specific to the chemical report. This drop-down menu displays
the following options: ‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical
Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values displayed within each of the drop-down menus
on the ‘Studies Previously Sent to Federal Agencies Without Confidentiality Claims’ pop-up
window. If you have multiple documents that share the same effects and/or endpoints, you must
upload each individual document separately and select values from the drop-down menus.
Exhibit 3-36 shows the screen capture of the ‘Studies Previously Sent To Federal Agencies
Without Confidentiality Claims’ pop-up window:
Exhibit 3-36: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Pop-Up Window
Exhibit 3-37 shows the screen capture of the ‘Studies Previously Sent To Federal Agencies
Without Confidentiality Claims’ screen when you select the ‘Add Studies’ radio button:
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Exhibit 3-37: Studies Previously Sent To Federal Agencies Without Confidentiality Claims
Screen (Add Study)
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Navigation: Once all required information has been entered, you are finished with the data entry
process. If information has been claimed as CBI, you will be required to complete the
substantiation screen for the AO to submit the form successfully. Please refer to Section 3.7 for
information regarding the substantiation section.
3.5
EPA Request for Further Information
The following screens are only available to you when you are amending a previous submission.
3.5.1
Underlying Data Screen
You can access the ‘Underlying Data’ screen by checking the ‘Underlying Data’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Underlying Data’ link within the navigation tree.
You can upload underlying data documents by clicking the ‘Add Document’ button. Clicking the
‘Add Document’ button generates a pop-up window for you to upload a document. To add
additional documents, click the ‘Add Document’ button each time from the ‘Underlying Data’
screen. You can delete any unwanted attached documents by clicking the ‘Delete’ icon within
the ‘Actions’ column of the underlying data table on the ‘Underlying Data’ screen. To attach a
different document after one has previously been attached, click the file name link for the desired
document under the ‘File Name’ column. Once you click the ‘File Name’ link of the desired
document, this generates the pop-up window that will display to attach the new document.
Attaching a new document will overwrite the existing document. The changes will commit once
you click the ‘OK’ button.
After all desired documents have been attached; click the ‘Next’ button to navigate to the next
study type identified on the ‘Study Identification’ screen. If no other study types have been
identified, click the ‘Next’ button to navigate to the ‘Submitter Request’ screen.
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Exhibit 3-38 shows the screen capture of the ‘Underlying Data’ screen:
Exhibit 3-38: Underlying Data Screen
The ‘Underlying Data’ pop-up window allows you to browse for a document from your hard
drive and attach one document at a time. You must attach at least one document. Clicking the
‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select the document
you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then a sanitized
copy of the document must be attached. To save the attached document to the ‘Underlying Data’
screen, click the ‘OK’ button within the ‘Underlying Data’ pop-up window.
• Add Document: Click the button to generate the ‘Underlying Data’ pop-up window and
attach an underlying data document.
• File Name: Displays the file name and file extension of the document attached on the
‘Underlying Data’ pop-up window.
• CBI: Indicates the CBI status of a document by displaying either a ‘Y’ or an ‘N.’
• Actions: Click the ‘Delete’ icon ( ) to remove the document from the system. A message
displays to confirm the removal of the document.
• CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field.
• Document Upload: Clicking the ‘Browse’ button will generate the ‘File Upload’ window
for you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the ‘CBI’ checkbox
is checked. Clicking the ‘Browse’ button will generate the ‘File Upload’ window for you
to search for a particular file on your hard drive.
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• Effects: Select the effect specific to the chemical report. This drop-down menu displays
the following options: ‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical
Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values displayed within each of the drop-down menus
on the ‘Underlying Data’ pop-up window. If you have multiple documents that share the same
effects and/or endpoints, you must upload each individual document separately and select values
from the drop-down menus.
Exhibit 3-39 shows the screen capture of the ‘Underlying Data’ pop-up window:
Exhibit 3-39: Underlying Data Pop-Up Window (with Sanitized Document Attached)
Navigation: Upload all required documents and click the ‘OK’ button to close the window and
populate the underlying data table. If you click ‘Cancel’ or the ‘X’ button, the window will close
but no data will be saved. Once all documents have been uploaded, click the ‘Next’ button to
move to the next screen from the ‘Underlying Data’ screen.
3.5.2
Preliminary Report of Ongoing Studies Screen
You can access the ‘Preliminary Reports of Ongoing Studies’ screen by checking the
‘Preliminary Reports of Ongoing Studies’ checkbox on the ‘Study Identification’ screen and
clicking the ‘Next’ button. You can also access this screen by clicking the ‘Preliminary Reports
of Ongoing Studies’ link within the navigation tree.
The ‘Preliminary Reports of Ongoing Studies’ screen is required for users who list studies as
ongoing or initiated. The ‘Preliminary Reports of Ongoing Studies’ screen provides the user with
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‘Add Documents’ and ‘Add Studies’ radio buttons. If you select the ‘Add Documents’ radio
button the system generates the ‘Add Document’ button and the preliminary reports of ongoing
studies table. Clicking the ‘Add Document’ button generates a pop-up window for you to upload
documents. To add additional documents click the ‘Add Document’ button from the ‘Preliminary
Reports of Ongoing Studies’ screen. You can delete unwanted attached documents by clicking
the ‘Delete’ icon within the ‘Actions’ column of the preliminary reports of ongoing studies table.
To attach a replacement document for a document that was previously attached, click the file
name link for the desired document under the ‘File Name’ column. Once you click the file name
link of the desired document, the attachment pop-up window generates for you to attach a new
document. Attaching a new document will overwrite the existing document. The changes will
commit once you click the ‘OK’ button.
If you select the ‘Add Study’ radio button, the system will generate the ‘Add Study’ button.
Clicking the ‘Add Study’ button will generate a field set that displays text fields for you to enter
required study information. You are required to identify the beginning date of the study, the
purpose of the study, types of data to be collected, the anticipated date of completion, and the
name and address of the laboratory conducting the study. This information must accompany each
listed entry.
The system provides the following text fields to complete:
• Add Documents: Select the radio button to attach a preliminary reports of ongoing studies
document.
• Add Studies: Select the radio button to enter preliminary reports of ongoing studies
information.
• Study Title: Enter the title of the study. This is a required field.
• Study Start Date: Enter the start date of the study. You can use the calendar widget to help
find a specific date. This is a required field.
• Study End Date: Enter the end date of the study. You can use the calendar widget to help
find a specific date. This is a required field.
• Study Purpose: Enter the purpose of the study. This is a required field.
• Data to be Collected: Enter the type of data to be collected throughout the duration of the
specified study. This is a required field.
• Create a new Laboratory or select an existing one from the drop-down: Displays
laboratories which have previously been entered within the same form, or allows you to enter
a new laboratory. This field is optional.
• CBI: Check the ‘CBI’ checkbox to claim the information of the laboratory conducting the
study as confidential.
• Laboratory Name: Enter the name of the laboratory conducting the study. This is a required
field.
• Mailing Address 1: Enter the first line of the mailing address of the laboratory conducting
the study. This is a required field.
• Mailing Address 2: Enter the second line of the mailing address of the laboratory
conducting the study.
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• City: Enter the city of the mailing address of the laboratory conducting the study. This is a
required field.
• State: Select the state of the mailing address of the laboratory conducting the study. This is a
required field if the country is identified as ‘United States.’
• Postal Code: Enter the postal code of the mailing address of the laboratory conducting the
study. This is a required field.
• Country: Select the country of the mailing address of the laboratory conducting the study.
This is a required field.
The system provides functionality for you to associate multiple studies to a single laboratory.
Once you enter laboratory contact information and save the data entered within the field set by
clicking the ‘Save’ button, that contact information is saved to the ‘Create a new laboratory or
select an existing one from the drop-down’ menu. You can click the ‘Delete’ icon located in the
top right corner of the specified field set to delete any unwanted studies. Clicking the ‘Expand
All’ link will expand all field sets. Likewise, clicking the ‘Collapse All’ link will collapse all
field sets. To expand or collapse a field set individually, click the toggle arrow located in the top
left corner of the specified field set.
After all information has been entered into the ‘Preliminary Reports of Ongoing Studies’ screen,
navigate to the next study identified on the ‘Study Identification’ screen by clicking the ‘Next’
button or by clicking the next study link in the navigation tree. If no other study types were
identified, you will be taken to ‘Submitter Request’ screen upon clicking the ‘Next’ button.
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Exhibit 3-40 shows the screen capture of the ‘Preliminary Reports of Ongoing Studies’ screen:
Exhibit 3-40: Preliminary Reports of Ongoing Studies Screen (Add Document)
The ‘Preliminary Reports of Ongoing Studies’ pop-up window allows you to browse for a
document from your hard drive and attach one document at a time. You must attach at least one
document. Clicking the ‘Browse’ button will generate the ‘File Upload’ window on your hard
drive. Select the document you wish to attach and click the ‘Open’ button. If a document is
marked as ‘CBI’ then a sanitized copy of the document must be attached. To save the attached
document to the ‘Preliminary Reports of Ongoing Studies’ screen, click the ‘OK’ button within
the ‘Preliminary Reports of Ongoing Studies’ pop-up window.
• CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field.
• Document Upload: Click the ‘Browse’ button to generate the ‘File Upload’ window for
you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the ‘CBI’ checkbox
is checked. Click the ‘Browse’ button to generate the ‘File Upload’ window for you to
search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. This drop-down menu displays
the following options: ‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical
Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
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Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Preliminary Reports of Ongoing Studies’ pop-up window. If you have multiple
documents that share the same effects and/or endpoints, you must upload each individual
document separately and select values from the drop-down menus.
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Exhibit 3-41 shows the screen capture of the ‘Preliminary Reports of Ongoing Studies’ pop-up
window:
Exhibit 3-41: Preliminary Report of Ongoing Studies Pop-Up Window (with Sanitized
Document Attached)
Exhibit 3-42 shows the screen capture of the ‘Preliminary Reports of Ongoing Studies’ screen
when you select the ‘Add Studies’ radio button:
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Exhibit 3-42: Preliminary Report of Ongoing Studies Screen (Add Study)
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Navigation: Once all required information is entered, click the ‘Next’ button to navigate to the
next screen. The next screen is dependent upon the study types you identified on the ‘Study
Identification’ screen.
3.5.3
Copies of Studies Screen
You can access the ‘Copies of Studies’ screen by checking the ‘Copies of Studies’ checkbox on
the ‘Study Identification’ screen and clicking the ‘Next’ button. You can also access this screen
by clicking the ‘Copies of Studies’ link within the navigation tree.
The ‘Copies of Studies’ screen provides you with ‘Add Documents’ and ‘Add Studies’ radio
button options. Selecting the ‘Add Documents’ radio button generates the ‘Add Document’
button and the copies of studies table. Clicking the ‘Add Document’ button generates the ‘Copies
of Studies’ pop-up window for you to upload documents. To add additional documents you can
click the ‘Add Document’ button as needed from the ‘Copies of Studies’ screen. You can delete
unwanted attached documents by clicking the ‘Delete’ icon located in the ‘Actions’ column of
the ‘Copies of Studies’ table. To attach a replacement document for a document that was
previously attached, click the file name link for the desired document under the ‘File Name’
column. Once you click the file name link of the desired document, the attachment pop-up
window generates for you to attach a new document. Attaching a new document will overwrite
the existing document. The changes will commit once you click the ‘OK’ button.
If you select the ‘Add Study’ radio button the system generates a field set to enter study
information. Clicking the ‘Add Studies’ radio button generates a field set that displays text fields
for you to enter required study information. You are required to identify the study title, and the
name and address of the contact who possesses a copy of the indicated study. This information
must accompany each listed entry.
The system provides the following text fields to complete:
• Add Documents: Select the radio button to attach copies of studies documentation. One
radio button must be selected.
• Add Studies: Select the radio button to enter copies of studies information. One radio button
must be selected.
• Study Title: Enter the title of the study. This field is required.
• CBI: Check the ‘CBI’ checkbox to identify the information of the individual who possesses a
copy of the indicated study as confidential.
• Prefix: If applicable, select the prefix of the individual who possesses a copy of the indicated
study.
• First Name: Enter the first name of the individual who possesses a copy of the indicated
study. This field is required.
• Last Name: Enter the last name of the individual who possesses a copy of the indicated
study. This field is required.
• Suffix: If applicable, select the suffix of the individual who possesses a copy of the indicated
study.
• Phone Number: Enter the phone number of the individual who possesses a copy of the
indicated study. This field is required.
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• Ext: Enter the extension to the phone number of the individual who possesses a copy of the
indicated study.
• Email Address: Enter the email address of the individual who possesses a copy of the study.
The email address must follow the standard email address format: [email protected]. This
field is required.
• Mailing Address 1: Enter the first line of the mailing address of the individual who
possesses a copy of the study. This field is required.
• Mailing Address 2: Enter the second line of the mailing address of the individual who
possesses a copy of the study.
• City: Enter the city of the mailing address of the individual who possesses a copy of the
study. This field is required.
• State: Select the state of the mailing address of the individual who possesses a copy of the
study. This field is required if the country selected is ‘United States.’
• Postal Code: Enter the postal code of the mailing address of the individual who possesses a
copy of the study. This field is required.
• Country: Select the country of the mailing address of the individual who possess a copy of
the study. This field is required.
The system provides functionality for you to associate multiple studies to a single contact. Once
you enter contact information and save the data entered within the field set by clicking the ‘Save’
button, that contact information is saved to the ‘Create a new contact or select an existing one
from the drop-down’ menu. You can click the ‘Delete’ icon located in the top right corner of the
specified field set to delete any unwanted studies. Clicking the ‘Expand All’ link will expand all
field sets. Likewise, clicking the ‘Collapse All’ link will collapse all field sets. To expand or
collapse a field set individually, you can click the toggle arrow located in the top left corner of
the specified field set.
After all required information has been entered into the ‘Copies of Studies’ screen, you can
navigate to the next study identified on the ‘Study Identification’ screen by clicking the ‘Next’
button or by clicking the next study link from within the navigation tree.
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Exhibit 3-43 shows the screen capture of the ‘Copies of Studies’ screen:
Exhibit 3-43: Copies of Studies Screen (Add Document)
The ‘Copies of Studies’ pop-up window allows you to browse for a document from your hard
drive and attach one document at a time. You must attach at least one document. Clicking the
‘Browse’ button will generate the ‘File Upload’ window on your hard drive. Select the document
you wish to attach and click the ‘Open’ button. If a document is marked as ‘CBI’ then a sanitized
copy of the document must be attached. To save the attached document to the ‘Copies of
Studies’ screen, click the ‘OK’ button within the ‘Copies of Studies’ pop-up window.
• CBI: Check the ‘CBI’ checkbox to claim the uploaded document as CBI and generate a
sanitized document upload field.
• Document Upload: Click the ‘Browse’ button to generate the ‘File Upload’ window for
you to search for a particular file on your hard drive.
• Sanitized Document Upload: This field will only be displayed when the ‘CBI’ checkbox
is checked. Click the ‘Browse’ button to generate the ‘File Upload’ window for you to
search for a particular file on your hard drive.
• Effects: Select the effect specific to the chemical report. This drop-down menu displays
the following options: ‘Health Effects,’ ‘Environmental Fate,’ ‘Ecotoxicity,’ and ‘Physical
Chemical Properties.’
• Endpoints: Select an endpoint that is specific to the chemical report. The endpoints will
be specific to the effect chosen from the ‘Effects’ drop-down menu. If no effect is chosen,
no endpoints will display.
Refer to Appendix B for a complete list of values that are found within each of the drop-down
menus on the ‘Document Management’ pop-up window. If you have multiple documents that
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share the same effects and/or endpoints, you must upload each individual document separately
and select values from the drop-down menus.
Exhibit 3-44 shows the screen capture of the ‘Copies of Studies’ pop-up window:
Exhibit 3-44: Copies of Studies Pop-up Window (with Sanitized Document Attached)
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Exhibit 3-45 shows the screen capture of the ‘Copies of Studies’ screen when you select the
‘Add Studies’ radio button:
Exhibit 3-45: Copies of Studies Screen (Add Study)
Navigation: Once all required information is entered, click the ‘Next’ button to navigate to the
next screen. The next screen is dependent upon the study types you identified on the ‘Study
Identification’ screen. If no other study types were identified you will navigate to the ‘Submitter
Requests’ screen upon clicking ‘Next.’
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3.6
Submitter Requests Screen
You can access the ‘Submitter Requests’ screen by clicking the ‘Submitter Requests’ link within
the navigation tree, or by clicking the ‘Next’ button from the previous screen.
The ‘Submitter Requests’ screen provides functionality for you to request a time extension or
withdrawal of a submission. Clicking the ‘Add Document’ button generates the ‘Submitter
Request’ pop-up window. You can delete unwanted attached documents by clicking the ‘Delete’
icon located in the ‘Actions’ column of the submitter requests table. To attach or edit a
previously attached document, click the file name link of the desired document under the ‘File
Name’ column. Once you click the file name link of the desired document, the attachment popup window generates for you to attach a new document. Attaching a new document will
overwrite the existing document. The changes will commit once you click the ‘OK’ button.
• File Name: Displays the file name and file extension of the document attached on the
‘Submitter Request’ pop-up window.
• Request Type: Displays the request type selected from the ‘Submitter Request’ pop-up
window.
• Actions: Click the ‘Delete’ icon ( ) to remove the document from the system. A warning
message displays to confirm removal of the document.
Exhibit 3-46 shows the screen capture of the ‘Submitter Requests’ screen:
Exhibit 3-46: Submitter Requests Screen
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Exhibit 3-47 shows the screen capture of the ‘Submitter Request’ pop-up window:
Exhibit 3-47: Submitter Request Pop-Up Window
Navigation: Click the ‘OK’ button to close the ‘Submitter Request’ pop-up window and save the
selected document. Clicking the ‘Cancel’ or ‘X’ button will close the window, however no data
will be saved. Once all documentation has been uploaded, click ‘Submit’ button to begin the
submission process. If data has been claimed as CBI, click the ‘Next’ button to complete the
‘Substantiation Summary’ screen.
3.7
Substantiation Summary
You can access the ‘Substantiation Summary’ screen by identifying CBI claims within the
application.
If a user claims any item as CBI, a prompt will display informing the user ‘Substantiation is
required.’ Please complete the substantiation by clicking the link within the navigation tree on
the left to complete substantiation for this item, or by clicking the ‘Next’ button from the
‘Submitter Request’ screen. To pass validation, substantiation must be completed for all items
claimed as CBI before submission. The ‘Substantiation Summary’ link within the navigation tree
provides access to the ‘Substantiation Summary’ screen. ‘Substantiation Status’ indicates
whether the user has completed substantiation. Click the ‘Pending’ link within the
‘Substantiation Status’ column if the status of the submission is ‘Pending’. Once the
substantiation has been completed, the status will change to ‘Complete.’
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Exhibit 3-48 shows the screen capture for the ‘Substantiation Summary’ screen:
Exhibit 3-48: Substantiation Summary Screen
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Exhibit 3-49 shows the screen capture of the ‘Submission of Studies Substantiation’ screen:
Exhibit 3-49: Submission of Studies Substantiation Screen
Navigation: Once all substantiation statuses are complete, click the ‘Submit’ icon to begin the
submission process.
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4
Validate
You can click the ‘Validate’ icon ( ) at any stage of completing a Section 8(d) Health & Safety
Data Reporting submission. The ‘Section 8(d) Health & Safety Data Reporting Validation’ popup window displays when you click the ‘Validate’ icon ( ). The ‘Section 8(d) Health & Safety
Data Reporting Validation’ pop-up window displays a report of all validation errors and warning
messages. During the validation process, the application validates each screen of the Section 8(d)
Health & Safety Data Reporting submission to find missing and invalid data.
Validation Errors: Errors are denoted by an ‘Error’ icon ( ) and can be fixed by clicking the
error link. The links will display the Screen Title Name (e.g., Technical Contact Information) and
the associated error. After you click a link, the main application screen will display the section
where the error occurred so you can easily fix the error. Once you have fixed the error, click the
‘Validate’ icon ( ) again to refresh the ‘Section 8(d) Health & Safety Data Reporting
Validation’ pop-up window. If the information you fixed passes validation, the error will be
removed from the ‘Section 8(d) Health & Safety Data Reporting Validation’ pop-up window.
You must fix all validation errors in order to submit the submission to CDX successfully.
You can close the ‘Section 8(d) Health & Safety Data Reporting Validation’ pop-up window by
clicking the ‘X’ button located at the top right of the window.
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Exhibit 4-1 shows the screen capture for the ‘Section 8(d) Health & Safety Data Reporting
Validation’ pop-up window:
Exhibit 4-1: Section 8(d) Health & Safety Data Reporting Validation Pop-Up Window
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5
Submit to EPA via CDX
As the Primary AO, you have the ability to sign and submit Section 8(d) Health & Safety Data
Reporting submissions to EPA. Any assigned Supports for your submissions do not have access
rights to submit to EPA via CDX.
Once you complete all required information and correct all items failing validation, the system
will allow you to successfully submit.
5.1
Submitting Official Information Screen
Click the ‘Submit’ icon ( ) located in the bottom action bar of the Section 8(d) Health & Safety
Data Reporting application to access the ‘Submitting Official Information’ screen. This screen is
only displayed to the Primary AO upon submission.
After clicking the ‘Submit’ icon ( ), the system requires you to review your contact
information provided during CDX registration. The system also requires you to identify your job
title.
Exhibit 5-1 shows the screen capture of the ‘Submitting Official Information’ screen:
Exhibit 5-1: Submitting Official Information Screen
Navigation: Click the ‘Next’ button to continue the submission process and proceed to the
‘Submission Process: Validation’ screen.
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5.2
Submission Process: Validation Screen
You can access the ‘Submission Process: Validation’ screen by clicking the ‘Next’ button from
the ‘Submitting Official Information’ screen.
This step in the submission process will validate the information entered within the Section 8(d)
Health & Safety Data Reporting submission.
Exhibit 5-2 shows the screen capture of the ‘Submission Process: Validation’ screen:
Exhibit 5-2: Submission Process: Validation Screen
After the Section 8(d) Health & Safety Data Reporting submission is verified, a PDF is generated
for the user to view.
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Exhibit 5-3 shows the screen capture of the ‘Submission Process: PDF Generation’ screen:
Exhibit 5-3: Submission Process: PDF Generation Screen
Navigation: Click the ‘Continue’ button to continue the submission process and proceed to the
‘Cross-Media Electronic Reporting Regulation (CROMERR) Certification’ screen. Click the
‘View PDF’ button to view a copy of the Section 8(d) Health & Safety Data Reporting
submission.
5.3
Cross-Media Electronic Reporting Regulation (CROMERR) Certification Screen
You can access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Certification’
screen by clicking the ‘Continue’ button on the ‘Submission Process: PDF Generation’ screen.
CROMERR provides the legal framework for electronic reporting under all of EPA’s
environmental regulations.
After clicking the ‘Continue’ button, the system requires the user to certify that the submission is
CROMERR compliant. By clicking the ‘I Certify’ button on the ‘Cross-Media Electronic
Reporting Regulation (CROMERR) Certification’ screen, the user authenticates all of the
information entered in the submission. Clicking the ‘Cancel’ button will allow the user to
navigate back to the Section 8(d) Health & Safety Data Reporting application.
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Exhibit 5-4 shows the screen capture for the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Certification’ screen:
Exhibit 5-4: Cross-Media Electronic Reporting Regulation (CROMERR) Certification
Screen
Navigation: Click the ‘I Certify’ button to continue the submission process and proceed to the
‘Cross-Media Electronic Reporting Regulation (CROMERR) Login’ screen.
5.4
Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen
You can access the ‘CROMERR Login’ screen by clicking the ‘I Certify’ button on the
‘CROMERR Certification’ screen.
To submit the Section 8(d) Health & Safety Data Reporting submission, log in to CDX using the
credentials you provided during CDX registration:
• Please login with your CDX password: Enter your CDX registration password.
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Exhibit 5-5 shows the screen capture of the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Login’ screen:
Exhibit 5-5: Cross-Media Electronic Reporting Regulation (CROMERR) Login Screen
Navigation: Enter your CDX registration password and click the ‘Next’ button to continue the
submission process and proceed to the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Security Question’ screen.
5.5
CROMERR Security Question Screen
You can access the ‘CROMERR Security Question’ screen by entering your CDX registration
password and clicking the ‘Next’ button on the ‘CROMERR Login’ screen.
The ‘Cross-Media Electronic Reporting Regulation (CROMERR) Security Question’ screen
randomly selects and displays one of the five CROMERR eSIG-PIN questions that you answered
on the 20-5-1 question screen during CDX registration. Answer the CROMERR security
question and click the ‘Next’ button.
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Exhibit 5-6 shows the screen capture of the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Security Question’ screen:
Exhibit 5-6: Cross-Media Electronic Reporting Regulation (CROMERR) Security Question
Screen
Navigation: Answer the security question and click the ‘Next’ button to continue the submission
process and proceed to the ‘Submit to CDX’ screen.
5.6
Submit to CDX Screen
You can access the ‘Submit to CDX’ screen after answering the 20-5-1 security question and
clicking the ‘Next’ button on the ‘CROMERR Security Question’ screen.
On the ‘Submit to CDX’ screen, you will see a certification message. Read the message and
acknowledge it by clicking the ‘Confirm’ button. Once you click the ‘Confirm’ button, your
submission will be submitted to CDX.
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Exhibit 5-7 shows the screen capture of the ‘Submit to CDX’ screen:
Exhibit 5-7: Submit to CDX Screen
Navigation: Click the ‘Confirm’ button to navigate to the ‘Cross-Media Electronic Reporting
Regulation (CROMERR) Submission’ screen.
5.7
Cross-Media Electronic Reporting Regulation (CROMERR) Submission Screen
You can access the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Submission’
screen by acknowledging the certification to submit to CDX by clicking the ‘Confirm’ button on
the ‘Submit to CDX’ screen.
On the ‘Cross-Media Electronic Reporting Regulation (CROMERR) Submission’ screen, you
will see a message indicating the submission has been successfully submitted to CDX.
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Exhibit 5-8 shows the screen capture of the ‘Cross-Media Electronic Reporting Regulation
(CROMERR) Submission’ screen:
Exhibit 5-8: Cross-Media Electronic Reporting Regulation (CROMERR) Submission
Screen
Navigation: Click the ‘Finish’ button to navigate to the Section 8(d) Health & Safety Data
Reporting ‘Home’ screen. Click the ‘Submissions’ tab or link to find your locked, submitted
submission. The ‘Section 8(d) Health & Safety Data Reporting’ submissions screen will display
the submission with a ‘Lock’ icon ( ) under the ‘Action’ column and will display a status of
‘Submitted.’
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6
Download Copy of Record
To download a copy of record, navigate to the ‘Section 8(d) Health & Safety Data Reporting’
submissions screen and locate a submission with a status of ‘Submitted.’
Click the ’Copy of Record’ icon from the ‘Section 8(d) Health & Safety Data Reporting’
submissions screen. You will be taken to the ‘Enter Passphrase’ screen to login to CDX using
your CDX passphrase. Note that if you recently submitted your Section 8(d) Health & Safety
Data Reporting submission to CDX, the ‘Copy of Record’ icon may take 15-20 minutes to
display. In addition, you must refresh your submissions screen by clicking the refresh button on
the address bar of the browser in order for the ‘Copy of Record’ icon to display.
Exhibit 6-1 shows the screen capture of the ‘Download Copy of Record’ screen:
Exhibit 6-1: Download Copy of Record Screen
The ‘Download Copy of Record’ screen displays the ‘File Name,’ ‘File Type,’ ‘File Size,’ and
‘Actions’ columns in a table format. You can click the ‘Copy of Record’ icon in the ‘Actions’
column to download the individual document, PDF version of the submitted submission, or the
XML version of the Section 8(d) Health & Safety Data Reporting submission. When you click
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the ‘Copy of Record’ icon, the system will allow you to view or download the individual files
that were uploaded during the submission process.
Exhibit 6-2 shows a screen capture of the download prompt screen:
Exhibit 6-2: Download Prompt Screen
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7
Create an Amendment
To amend a submitted Section 8(d) Health & Safety Data Reporting submission, navigate to the
‘Section 8(d) Health & Safety Data Reporting’ submissions screen and locate a submission with
a status of ‘Submitted.’ In addition to displaying a status of ‘Submitted’ under the ‘Status’
column, the ‘Lock’ icon ( ) will display under the ‘Action’ column. Click the ‘Lock’ icon ( )
under the ‘Action’ column to start an amendment.
Exhibit 7-1 shows the screen capture of the ‘Section 8(d) Health & Safety Data Reporting’
submissions screen:
Exhibit 7-1: Section 8(d) Health & Safety Data Reporting Submissions Screen –
Amendment
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Navigation: After clicking the ‘Lock’ icon ( ), you will receive a prompt to confirm the
amendment process. If you unlock a submission, you will be required to resubmit the submission
to CDX after you have completed editing the submission. If you do not want to continue with the
amendment, click the ‘Cancel’ button to cancel the amendment process and return to the ‘Section
8(d) Health & Safety Data Reporting’ submissions screen. Click the ‘OK’ button to close the
prompt and continue with the amendment.
Exhibit 7-2 shows the screen capture of the ‘Unlock Prompt’ message:
Exhibit 7-2: Unlock Prompt Message
After you click the ‘OK’ button, you will be taken to the ‘Enter Passphrase’ screen. You must
enter the passphrase originally associated with the submission to start the amendment process.
After you enter the passphrase and click the ‘Next’ button, you will be taken to the ‘Technical
Contact Information’ screen. Refer to Section 3.4.3 for further instructions on the ‘Enter
Passphrase’ screen.
After a submission has been unlocked, the ‘Section 8(d) Health & Safety Data Reporting’
submissions screen will display a status of ‘In Progress’ under the ‘Status’ column, and the
‘Unlocked’ icon ( ) will display under the ‘Action’ column; however, you will not see these
changes until you navigate back to the ‘Section 8(d) Health & Safety Data Reporting’
submissions screen.
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8
Resources
You can access the ‘Resources’ screen by clicking the ‘Resources’ tab located in the application
header. You can also access the ‘Resources’ screen by clicking the ‘Resources’ link from the
Section 8(d) Health & Safety Data Reporting ‘Home’ screen. The ‘Resources’ screen provides
you with links to all of the Section 8(d) Health & Safety Data Reporting application user guides
as well as additional helpful links. Click the ‘User Guide’ links to access the Section 8(d) Health
& Safety Data Reporting user guide document.
Section 8(d) Health and Safety Data Reporting Homepage: If you click this link, a new
internet browser window will generate displaying the ‘Section 8(d) Health and Safety Data
Reporting’ screen.
CDX Home: If you click this link, a new internet browser window will generate displaying the
‘CDX Homepage.’
TSCA Chemical Substances Inventory: If you click this link, a new internet browser window
will generate displaying the ‘TSCA Chemical Substances Inventory’ screen.
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Exhibit 8-1 shows the screen capture of the ‘Resources’ screen:
Exhibit 8-1: Resources Screen
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Appendix A. Definitions, Acronyms, and Abbreviations
The following is a list of all the definitions, acronyms, and abbreviations used in this document
and their full name.
Definitions, Acronyms, and Abbreviations
Acronym
Full Name
AO
Authorized Official
CA
Chemical Abstract
CASRN
Chemical Abstract Services Registry Number
CBI
Confidential Business Information
CDX
Central Data Exchange
CFR
Code of Federal Regulation
CoR
Copy of Record
CROMERR
Cross-Media Electronic Reporting Regulation
CSPP
Chemical Safety and Pesticide Programs
CSV
Comma Separated Values
EPA
Environmental Protection Agency
EST
Eastern Standard Time
FRN
Federal Register Notice
IUPAC
International Union of Pure and Applied Chemistry
OPPT
Office of Pollution Prevention and Toxics
PDF
Portable Document Format
PMN
Premanufacture Notice
SRS
Substance Registry Services
TSCA
Toxic Substances Control Act
XML
Extensible Markup Language
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Appendix B. Submission Types, Effects, and Endpoints
The following appendix displays all possible options within each drop-down menu on the
‘Document Management’ pop-up window.
First Dropdown:
• Title: Submission Type
• Contains the following values
o Initial Submission
o Follow-Up Submission
o Final Submission
Second Dropdown
• Title: Summary/Abstract Submission
• Contains the following values
o Yes
o No
Third Dropdown
• Title: Effects
• Contains the following values
o Health Effect
o Ecotoxicity
o Environmental Fate
o Physical-Chemical Properties
Fourth Dropdown
• Title: Endpoints
• Contains the following values
o For Health Effect (shows when Health Effect is selected from third dropdown)
Basic Toxic kinetics
Dermal Absorption
Acute Toxicity: oral
Acute Toxicity: inhalation
Acute Toxicity: dermal
Acute Toxicity: other routes
Skin irritation/corrosion
Eye irritation
Skin sensitization
Respiratory sensitization
Repeated Dose toxicity: oral
Repeated Dose toxicity: inhalation
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Repeated Dose Toxicity: dermal
Repeated Dose Toxicity: other routes
Genetic Toxicity in vitro
Genetic Toxicity in vivo
Carcinogenicity
Toxicity to Reproduction
Developmental Toxicity/teratogenicity
Toxicity to reproduction: other studies
Neurotoxicity
Immunotoxicity
Specific investigations: other studies
Health surveillance data
Epidemiological data
Direct observations: clinical cases, poisoning incidents and other
Sensitization data (humans)
Exposure related observations in humans: other data
Toxic effects on livestock and pets
Additional toxicological information
Other
o For Ecotoxicity (shows when Ecotoxicity is selected from third dropdown)
Short-term toxicity to fish
Long-term toxicity to fish
Short-term toxicity to aquatic invertebrates
Long-term toxicity to aquatic invertebrates
Toxicity to aquatic algae and cyanobacteria
Toxicity to aquatic plants other than algae
Toxicity to microorganisms
Toxicity to other aquatic organisms
Sediment toxicity
Toxicity to soil macroorganisms except arthropods
Toxicity to terrestrial arthropods
Toxicity to terrestrial plants
Toxicity to soil microorganisms
Toxicity to birds
Toxicity to other above-ground organisms
Biological effects monitoring
Biotransformation and kinetics
Additional ecotoxicological information
Other
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o For Environmental Fate (shows when Environmental Fate is selected from third
dropdown)
Photo transformation in air
Hydrolysis
Photo transformation in water
Photo transformation in soil
Biodegradation in water: screening test
Biodegradation in water and sediment: simulation tests
Biodegradation in soil
Mode of degradation in actual use
Bioaccumulation: aquatic/sediment
Bioaccumulation: terrestrial
Adsorption/desorption
Henry's Law constant
Distribution Modeling
Other Distribution Data
Monitoring Data
Field Studies
Additional Information on Environmental Fate and Behavior
Other
o For Physical-Chemical Properties (shows when Physical-Chemical Properties is
selected from third dropdown)
Appearance/Physical
Melting Point
Boiling Point
Density
Particle size distribution
Vapor Pressure
Partition Coefficient
Water Solubility
Solubility in Organic Solvent
Surface Tension
Flash Point
Auto Flammability
Flammability
Explosiveness
Oxidizing Properties
Oxidation Reduction Potential
Stability in organic solvents and identity of relevant degradation products
Storage stability and reactivity towards container material
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Stability: thermal, sunlight, metals
pH
Dissociation constant
Viscosity
Additional physic-chemical information
Other
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| File Type | application/pdf |
| File Title | EPA Functional Design Document Template |
| Author | Robert Parker |
| File Modified | 2013-11-19 |
| File Created | 2013-10-22 |